(168 days)
Not Found
No
The device description and intended use clearly describe a purely mechanical lancing device for blood sampling. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is used to obtain a blood sample for diagnostic purposes (glucose monitoring), not to directly treat a medical condition.
No
Explanation: The device is a lancing device used to obtain a blood sample. It does not perform any diagnostic analysis of the sample itself. Its function is solely to facilitate the collection of blood for diagnostic tests conducted by other devices.
No
The device is described as a "mechanical device" that "holding and firing a single-use lancet linearly ahead to prick the skin". This clearly indicates a physical, hardware-based device, not software.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The tests are performed in vitro (in a lab setting, outside the body).
- Function of the Device: The description clearly states that the device is a "mechanical device holding and firing a single-use lancet linearly ahead to prick the skin to collect capillary whole blood from target sites." Its purpose is to obtain the sample, not to test the sample.
- Intended Use: The intended use is for "capillary blood sampling for glucose monitoring or other test that require one or two drops of blood." This reinforces that the device is a tool for sample collection, not for performing the diagnostic test itself.
While the blood sample collected by this device can be used for an IVD test (like glucose monitoring), the lancing device itself is a sample collection tool, not an IVD.
N/A
Intended Use / Indications for Use
RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
GE Lancing Device is a reusable lancing device for the single used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.
Product codes (comma separated list FDA assigned to the subject device)
ORL, QRL
Device Description
RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device is a mechanical device holding and firing a single-use lancet linearly ahead to prick the skin to collect capillary whole blood from target sites. RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device can be adjusted for 7 levels of depth for a user collecting different amount of capillary blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single user
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided to demonstrate the safety and efficacy:
- ISO 10993-5 In vitro Cytotoxicity A.
- ISO 10993-23 Skin Irritation B.
- C. ISO 10993-10 Skin Sensitization (Maximization Test)
- D. Functional tests were validated and completed.
- E. The cleaning and disinfections on the materials of device were evaluated and tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name in a smaller font below.
September 26, 2022
Bionime Corporation % I Hsin Li Regulatory Consultant Symbiosis Consulting Ltd. 11F., No.95, Sec. 2, Nanjing E. Rd., Zhongshan Dist., Taipei, 10489 Taiwan
Re: K221062
Trade/Device Name: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL Dated: August 26, 2022 Received: August 26, 2022
Dear I Hsin Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221062
Device Name BIONIME CORPORATION
Indications for Use (Describe)
RIGHTEST Lancing Device GD500
RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
GE Lancing Device
GE Lancing Device is a reusable lancing device for the single used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
iGlucose Lancing Device
iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "BIONIN" in a stylized, sans-serif font. The letters are large and appear to be a light gray or white color. The background is plain white, which makes the text stand out.
SECTION 5-510(k) SUMMARY
This 510 (K) summary is being submitted in accorndance with requirements of
ithe 21,CFR Section 807.92.
| A. | 510(k) NUMBER | K221062 |
|---|---|---|
| B. | DATE PREPARED | September 25th, 2022 |
| C. | SUBMITTER | BIONIME CORPORATION |
| NO. 100, Section 2, Daqing Street., South District, | ||
| Taichung City, Taiwan, 40242 | ||
| Registration Number: 3004183148 | ||
| FEI Number: 3004183148 | ||
| Tel: +886 4 23692388 | ||
| D. | CONTACT PERSON | Primary Contact Person |
| Engineer | ||
| Name: Yu Chi Huang | ||
| Tel: +886 4 23692388#5898 | ||
| E-mail: Yuchi.huang@bionime.com |
Second Contact Person
Regulatory Consultant
Name: I Hsin Li
Tel: +886 2 6605 7988
E-mail: contact@symbiosistw.com |
| E. | DEVICES | Proprietary Name: RIGHTEST Lancing Device GD500
Common Name: Multiple Use Blood Lancet For Single Patient Use Only
Product Code: QRL
Regulation Number: 21 CFR 878.4850
Device Class: Class II
Review Panel: General & Plastic Surgery
Proprietary Name: GE Lancing Device
Common Name: Multiple Use Blood Lancet For Single Patient Use Only
Product Code: QRL
Regulation Number: 21 CFR 878.4850
Device Class: Class II
Review Panel: General & Plastic Surgery |
| Proprietary Name: | iGlucose Lancing Device | |
| Common Name: | Multiple Use Blood Lancet For Single
Patient Use Only | |
| Product Code: | QRL | |
| Regulation Number: | 21 CFR 878.4850 | |
| Device Class: | Class II | |
| Review Panel: | General & Plastic Surgery | |
SECTION 5-510(k) SUMMARY Page 1 of 8 pages
4
Image /page/4/Picture/0 description: The image shows the word "BIONIME" in a stylized, sans-serif font. The letters are rendered in a light gray color, giving them a subtle, almost translucent appearance against the white background. The font choice and color scheme create a modern and clean aesthetic.
RIGHTEST Lancing Device GD500 F. INDICATION(S) FOR
USE
RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
GE Lancing Device
GE Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
iGlucose Lancing Device
iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.
SECTION 5-510(k) SUMMARY Page 2 of 8 pages
5
Image /page/5/Picture/0 description: The image shows the word "BIONIME" in a sans-serif font. The letters are all capitalized and appear to be a light gray or white color. The background is a solid white, which makes the text stand out. The overall impression is clean and modern.
| G. | PRIMARY
PREDICATE DEVICE | Proprietary Name:
Common Name:
Product Code:
Regulation Number:
510(k) Number:
510(k) Submitter:
Device Class:
Review Panel: | On Call Lancing Device
Single Use Only Blood Lancet with An
Integral Sharps Injury Prevention Feature
FMK
21 CFR 878.4850
K113332
ACON Laboratories Inc.
Class II
General & Plastic Surgery |
|----|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| H. | SECONDARY
PREDICATE DEVICE | Proprietary Name:
Common Name:
Product Code:
Regulation Number:
Regulation Name:
510(k) Number:
510(k) Submitter:
Device Class:
Review Panel: | Genteel Lancing Device
Single Use Only Blood Lancet with An
Integral Sharps Injury Prevention Feature
FMK
21 CFR 878.4850
Blood lancets
K153670
Genteel LLC
Class II
General & Plastic Surgery |
| I. | DEVICE DECRIPTION | | RIGHTEST Lancing Device GD500/ GE Lancing Device/
iGlucose Lancing Device is a mechanical device holding and
firing a single-use lancet linearly ahead to prick the skin to
collect capillary whole blood from target sites. RIGHTEST
Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing
Device can be adjusted for 7 levels of depth for a user collecting
different amount of capillary blood. |
| J. | COMPARISON OF
TECHNOLOGICAL
CHARACTERISTICS
WITH THE
PREDICATE DEVICES | | RIGHTEST Lancing Device GD500, GE Lancing Device and
iGlucose Lancing Device and predicate devices (K113332 and
K113618) are:
- Same "intended use/ indication(s) for use"
- Same "Puncture device to obtain micro blood
samples" - Same "Clear cap for testing alternative site"
- Same "Lancet retracted after use to prevent sharp
injure" - Same "Mechanical loading and firing function"
- Same "Ejecting the used lancet Without touching the
used disposable lancet" - Different "The depth of penetration" |
6
Image /page/6/Picture/0 description: The image shows the word "BIONIME" in a light gray color. The letters are all capitalized and evenly spaced. The font appears to be sans-serif.
K221062
RIGHTEST Lancing Device GD500/GE Lancing
Device/iGlucose Lancing Device and predicate devices (K113332 and K153670) are all the same intended use/ indication(s) for use, intended population, similar technical design and functions. The varying setting in the depth of penetration between RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device and predicate devices did not raise other concerns on safety and efficacy.
BIONIME CORPORATION concluded that RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device is substantially equivalent to the predicate devices On Call Lancing Device and the Genteel Lancing Device (K113332 and K153670).
SECTION 5-510(k) SUMMARY
Page 4 of 8 pages
7
Image /page/7/Picture/0 description: The image shows the word "BIONIME" in a light gray, sans-serif font. The letters are large and spaced closely together, filling most of the frame. The background is a plain white, which makes the text stand out despite its light color. The overall impression is clean and modern.
K. A COMPARISON TABLE WITH PREDICATE DEVICES
| Items | Proposed Device
RIGHTEST Lancing Device GD500,
GE Lancing Device and iGlucose
Lancing Device | Primary Predicate Device
On Call Lancing Device | Secondary Predicate
Device
Genteel Lancing Device | Substantial
Equivalence
Comparison
Assessment |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) Number | TBD | K113332 | K153670 | N/A |
| Product Code | QRL | FMK | FMK | Different |
| Device
Classification | Class II | Class II | Class II | Same |
| Intended Use/
Indication(s) for Use | RIGHTEST Lancing Device
GD500 is a reusable lancing
device for the single user. It
should be used with the proper
sterile lancet for the capillary
blood sampling. It could
automatically inject the lancet
into and retract it from the
fingertip to obtain a capillary
blood sample for glucose
monitoring or other test that
require one or two drops of
blood. A depth adjustable cap
allows the best depth of skin
penetration for each individual
user. Alternative site testing
(palm or forearm) can be
performed by installing the clear
cap on the lancing device.
GE Lancing Device is a reusable
lancing device for the single
user. It should be used with the | The On Call® Lancing Device is
used with On Call® disposable
sterile lancets to draw capillary
blood from the fingertip, palm (at
the base of the thumb) or forearm,
for blood glucose testing or other
testing utilizing small amounts of
blood. The On Call® Lancing
Device is intended to be used by a
single patient and should not be
shared. | The Genteel lancing
device is used with
disposable sterile
lancets to draw
capillary blood
from the fingertip or
alternate sites for
blood glucose
testing or other
testing utilizing
small amounts of
blood. The Genteel
lancing device is for
Single Patient Use
Only. | Same |
8
Image /page/8/Picture/0 description: The image shows the word "BIONIME" in a light gray color. The letters are all capitalized and evenly spaced. The font appears to be sans-serif.
| K22 | 11 | 062 |
|---|---|---|
| Items | Proposed Device | Primary Predicate Device | Secondary Predicate Device | K22106
Substantial
Equivalence
Comparison
Assessment |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|
| | RIGHTEST Lancing Device GD500,
GE Lancing Device and iGlucose
Lancing Device | On Call Lancing Device | Genteel Lancing Device | |
| | proper sterile lancet for the
capillary blood sampling. It
could automatically inject the
lancet into and retract it from the
fingertip to obtain a capillary
blood sample for glucose
monitoring or other test that
require one or two drops of
blood. A depth adjustable cap
allows the best depth of skin
penetration for each individual
user. Alternative site testing
(palm or forearm) can be
performed by installing the clear
cap on the lancing device. | | | |
| | iGlucose Lancing Device is a
reusable lancing device for the
single user. It should be used
with the proper sterile lancet for
the capillary blood sampling. It
could automatically inject the
lancet into and retract it from the
fingertip to obtain a capillary
blood sample for glucose
monitoring or other test that
require one or two drops of
blood. A depth adjustable cap
allows the best depth of skin | | | |
| Items | Proposed Device
RIGHTEST Lancing Device GD500,
GE Lancing Device and iGlucose
Lancing Device | Primary Predicate Device
On Call Lancing Device | Secondary Predicate
Device
Genteel Lancing Device | Substantial
Equivalence
Comparison
Assessment |
| | penetration for each individual
user. | | | |
| Puncture device to
obtain micro blood
samples | Yes | Yes | Yes | Same |
| Clear cap for testing
alternative site | Yes | Yes | Yes | Same |
| Lancet retracted
after use to prevent
sharp injure | Yes | Yes | Yes | Same |
| Mechanical loading
and firing function | Yes | Yes | Yes | Same |
| Ejecting the used
lancet Without
touching the used
disposable lancet | Yes | Yes | Yes | Same |
| The depth of
penetration | 7 different depths
The settings of penetration depths are
0.5 mm, 0.7 mm, 0.9 mm 1.1 mm, 1.3
mm, 1.5 mm and 1.7 mm. | 6 different depths | six interchangeable
contact tips | Different |
| OTC/Rx | OTC | OTC | OTC | Same |
| Design | Image: RIGHTEST Lancing Device GD500, GE Lancing Device and iGlucose Lancing Device design | Image: On Call Lancing Device design | Image: Genteel Lancing Device design | Similar
design |
SECTION 5-510(k) SUMMARY
Page 6 of 8 pages
9
Image /page/9/Picture/0 description: The image shows the word "BIONIME" in a stylized, sans-serif font. The letters are rendered in a light gray color, giving them a subtle, almost translucent appearance against the white background. The font choice and color scheme create a modern and clean aesthetic.
SECTION 5-510(k) SUMMARY
Page 7 of 8 pages
10
Image /page/10/Picture/0 description: The image shows the word "BIONIME" in a sans-serif font. The letters are in a light gray color, and the background is white. The word is written in all capital letters and is centered in the image.
L. SUMMARY OF PERFORMANCE DATA
The following performance data were provided to demonstrate the safety and efficacy:
- ISO 10993-5 In vitro Cytotoxicity A.
- ISO 10993-23 Skin Irritation B.
- C. ISO 10993-10 Skin Sensitization (Maximization Test)
- D. Functional tests were validated and completed.
- E. The cleaning and disinfections on the materials of device were evaluated and tested.
- M. SUBSTANTIAL EQUIVALENCE CONCLUSION
BIONIME CORPORATION concludes that the RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device is substantially equivalent to predicate devices in regard to indications for use, design, and technology, without raising any safety and efficacy risks or concerns.