(88 days)
Not Found
No
The summary describes a mechanical lancing device and lancets, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on physical and biological properties, not algorithmic performance.
No.
The device is used for obtaining capillary blood samples, which is a diagnostic purpose, not a therapeutic one.
No
This device is used to obtain a blood sample, which can then be used for diagnostic purposes, but the device itself does not perform any diagnostic function.
No
The device description clearly states it consists of a "non-sterile, reusable base blood lancing device" and "sterile, single-use lancet," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to obtain a capillary blood sample from the fingertip. While this blood sample can be used for in vitro diagnostic testing (like blood glucose monitoring), the lancet itself is a tool for collecting the sample, not for performing the diagnostic test on the sample.
- Device Description: The description focuses on the physical characteristics and function of the lancing system (lancet and lancing device) for obtaining the blood sample.
- Lack of Diagnostic Function: There is no mention of the device analyzing the blood sample or providing any diagnostic information. It is purely a sample collection device.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This lancing system's function is in vivo (on the body) to obtain the specimen.
N/A
Intended Use / Indications for Use
The OneTouch® Delica® Plus lancets are sterile, single use designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The OneTouch Delica Plus lancets are compatible with the single patient use OneTouch® Delica® Plus lancing device.
Product codes
QRL, QRK
Device Description
The OneTouch® Delica® Plus Lancing System consists of a non-sterile, reusable base blood lancing device that is intended for use on a single patient and is used in conjunction with a sterile, single-use lancet. The lancing device has 13 depth settings. The lancets are made available in size 30G and are packaged in boxes of 30 and 100 count.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Lay users in a home or general environment.
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)
To demonstrate safety and effectiveness of the OneTouch® Delica® Plus Lancing System and to show substantial equivalence to the predicate device, Asahi Polyslider completed the following verification and validation activities, including non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The OneTouch® Delica® Plus Lancing System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Materials of Construction Specifications met
- Visual, Physical and Dimensional Verification – Specifications met
- Functional Testing – Specifications met
- Performance Testing – Specifications met
- Cleaning and Disinfection – Specification met
- Cytotoxicity Testing per ISO 10993-5 – Passed
- Sensitization Testing per ISO 10993-10 – Passed
- Irritation per ISO 10993-10 – Passed
- Sterilization Validation per ISO 11137-1/-2 – Demonstrates SAL 10^-6
- Product Sterility per ISO 11737-1 – Demonstrates product is free of microorganisms
- Shelf-life Testing per ASTM F1980 – Supports a shelf-life of 4 and 5 years
- Transportation Testing per ASTM 4169 – Demonstrates package integrity is maintained
- Risk Analysis per ISO 14971 – Hazards identified, ranked and risk mitigation measures implemented
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2022
Asahi Polyslider Co., Ltd. % Stuart Goldman Senior Consultant, RA/QA Emergo by UL 2500 Bee Cave Road, Bldg.1 Suite 300 Austin, Texas 78746
Re: K221546
Trade/Device Name: OneTouch Delica Plus Lancing System Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: Mav 25, 2022 Received: May 27, 2022
Dear Stuart Goldman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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)
Device Name
OneTouch® Delica® Plus Lancing System
Indications for Use (Describe)
The OneTouch® Delica® Plus lancets are sterile, single use designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The OneTouch Delica Plus lancets are compatible with the single patient use OneTouch® Delica® Plus lancing device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary OneTouch® Delica® Plus Lancing System
1. Submission Sponsor
Asahi Polyslider Company, Ltd. 860-2 Misaki, Maniwa Okayama 719-3226 Japan Yoshitaka Akagi Sr. Manager, Quality Assurance 0867-42-1171
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Stuart R. Goldman Sr. Consultant (512) 327-9997
3. Date Prepared
July 21, 2022
4. Device Identification
| Trade/Proprietary Name: | OneTouch® Delica® Plus Lancing System |
|---|---|
| Common/Usual Name: | Blood lancets |
| Classification Name: | Blood lancets |
| Regulation Number: | 878.4850 |
| Product Code: | QRL, QRK |
| Class: | II |
| Classification Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate Device
| Device name: | Accu-Chek Softclix Blood Lancing System |
|---|---|
| 510(k) number: | K214022 |
| Manufacturer: | Roche Diabetes Care, Inc. |
6. Indication for Use Statement
The OneTouch® Delica® Plus lancets are sterile, single use devices that have been designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The
4
OneTouch Delica Plus lancets are compatible with the single patient use OneTouch® Delica® Plus lancing device.
7. Device Description
The OneTouch® Delica® Plus Lancing System consists of a non-sterile, reusable base blood lancing device that is intended for use on a single patient and is used in conjunction with a sterile, single-use lancet. The lancing device has 13 depth settings. The lancets are made available in size 30G and are packaged in boxes of 30 and 100 count.
8. Substantial Equivalence Discussion
Table 5-1 compares the OneTouch® Delica® Plus Lancing System to the predicate device with respect to its intended use, indications for use, and technological characteristics and performance, forming the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | Asahi Polyslider | Roche |
| 510(k) # | Pending | K214022 |
| Product Codes | QRL/QRK | QRL/QRK |
| Device Name | OneTouch® Delica® Plus Lancing System | Accu-Chek Softclix Blood |
| Lancing System | ||
| Device | ||
| Description | The OneTouch® Delica® Plus Lancing System consists | |
| of the lancing device and compatible lancets to obtain | ||
| a drop of blood from a fingertip. | The Accu-Chek Softclix Lancing | |
| Device uses compatible Accu-Chek | ||
| Softclix Lancets to obtain a drop of | ||
| blood from a fingertip or alternative | ||
| sites using the Accu-Chek Softclix | ||
| Alternative Site Testing (AST) Cap. | ||
| Intended Use | For the hygienic collection of capillary blood for | |
| testing purposes. | For the hygienic collection of | |
| capillary blood for testing purposes. | ||
| Indications for | ||
| Use | The OneTouch® Delica® Plus lancets are sterile, single | |
| use devices that have been designed for single patient | ||
| use by lay users in a home or general environment. | ||
| Their intended use is for performing skin punctures on | ||
| patients for the purpose of obtaining capillary blood | ||
| samples from the fingertips. The OneTouch Delica Plus | ||
| lancets are compatible with the single patient use | ||
| OneTouch® Delica® Plus lancing device. | The Accu-Chek Softclix Blood | |
| Lancing System is intended for the | ||
| hygienic collection of capillary blood | ||
| for testing purposes from the side of | ||
| a fingertip and from alternative | ||
| sites, such as the palm, the upper | ||
| arm, and the forearm. | ||
| The sterile, single-use lancets are to | ||
| be used with the reusable lancing | ||
| device that is to be cleaned and | ||
| disinfected between each use, and | ||
| then the lancets are to be disposed | ||
| of. | ||
| Attribute | Subject Device | Predicate Device |
| This system is for use only on a | ||
| single patient in a home setting. | ||
| This system is not suitable for use by | ||
| healthcare professionals with | ||
| multiple patients in a healthcare | ||
| setting. | ||
| Type of Use | OTC | OTC |
| Mechanism of | ||
| Action | Spring-loaded | Spring-loaded |
| Lancet Sizes | ||
| (needle | ||
| diameter) | 30G | |
| 33G | 28G | |
| Depth | ||
| Adjustments | 13 levels | 11 levels |
| Anatomical | ||
| Site(s) | Fingertip | Fingertip |
| Ball of the hand | ||
| Upper arm | ||
| Lower arm | ||
| Materials | Lancing device housing: | |
| polymer | Lancing device housing: | |
| polymer | ||
| Lancet: cap and body (polymer), | ||
| needle (stainless steel) | Lancet: cap and body (polymer), | |
| needle (stainless steel) | ||
| Sharps Injury | ||
| Prevention | Yes (lancing device) | Yes (lancing device) |
| Sterile | Lancing device: no | Lancing device: no |
| Lancet: yes, gamma radiation | ||
| (SAL = $10^{-6}$ ) | Lancet: yes, gamma radiation | |
| (SAL = $10^{-6}$ ) | ||
| Single-Use | Lancing device: no, multiple use | Lancing device: no, multiple use |
| Lancet: yes | Lancet: yes | |
| Shelf-Life | Lancing device: (4 years) | |
| Lancet: (5 years) |
Table 5-1 – Substantial Equivalence Comparison of OneTouch® Delica® Plus Lancing System to the Predicate Device
5
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of the OneTouch® Delica® Plus Lancing System and to show substantial equivalence to the predicate device, Asahi Polyslider completed the following verification and validation activities, including non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The OneTouch® Delica® Plus Lancing System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
6
- Materials of Construction Specifications met ●
- . Visual, Physical and Dimensional Verification – Specifications met
- Functional Testing – Specifications met
- Performance Testing – Specifications met
- Cleaning and Disinfection – Specification met
- Cytotoxicity Testing per ISO 10993-5 – Passed
- . Sensitization Testing per ISO 10993-10 – Passed
- . Irritation per ISO 10993-10 – Passed
- Sterilization Validation per ISO 11137-1/-2 – Demonstrates SAL 10°
- . Product Sterility per ISO 11737-1 – Demonstrates product is free of microorganisms
- Shelf-life Testing per ASTM F1980 – Supports a shelf-life of 4 and 5 years
- . Transportation Testing per ASTM 4169 – Demonstrates package integrity is maintained
- . Risk Analysis per ISO 14971 – Hazards identified, ranked and risk mitigation measures implemented
10. Clinical Performance Data
No clinical tests were performed.
11. Substantial Equivalence Conclusion
The OneTouch® Delica® Plus Lancing System has the same intended use as the Accu-Chek Softclix Lancing System and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the subject device is as safe and effective as the predicate device. Therefore, the OneTouch® Delica® Plus Lancing System is substantially equivalent to the predicate device.