(55 days)
Not Found
No
The device description and performance studies focus on the physical components, sterilization, and biocompatibility of a simple lancet, with no mention of AI or ML capabilities.
No
The device is used for capillary blood sampling, a diagnostic procedure, not for treating a disease or condition.
No
The device, Sterile Lancets for Single Use, is intended for capillary blood sampling to obtain a drop of blood. It does not perform any analysis or interpretation of the blood sample, which are functions of a diagnostic device.
No
The device description explicitly states it is composed of two physical components: a needle and a needle holder. The performance studies also focus on physical characteristics and biological compatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "capillary blood sampling." This describes the collection of a sample, not the testing or analysis of that sample.
- Device Description: The device is a lancet, which is a tool for puncturing the skin to obtain blood. It does not perform any diagnostic testing on the blood itself.
- Lack of Diagnostic Function: There is no mention of any component or function that would analyze or test the blood sample. The device's purpose is solely to facilitate the collection of the sample.
- Performance Studies: The performance studies focus on the physical characteristics of the lancet (appearance, dimension, firmness, puncture performance, etc.) and its biocompatibility and sterility. These are relevant to a device used for sample collection, not for diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This lancet is a tool used before any diagnostic testing would occur.
N/A
Intended Use / Indications for Use
Lancet is intended for capillary blood sampling.
Product codes
QRK
Device Description
The Sterile Lancets for Single Use is intended for capillary blood sampling.
The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only.
The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites.
The shelf-life of the product is 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip or from alternative sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional or lay person
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
Performance Testing
Performance testing is conducted according to Inspection Specification, the test sample has undergone accelerated aging for 5.5 years.
Tested the following projects : Appearance, Dimension, Firmness of needle and main body, Puncture Performance, Matching, Launch Performance, Bacterial endotoxin, Sterilization
Biocompatibility testing
Biocompatibility of the Sterile Lancets for Single Use was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1" The following testing was conducted:
- A Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Sensitization ISO 10993-10:2021 Biological evaluation of medical devices Part 10: A Tests for skin sensitization
- Irritation ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Acute Systemic ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
- Pyrogenicity ISO 10993-11:2017 Biological evaluation of medical devices Part 11: A Tests for systemic toxicity
Sterility and Shelf -life
After five years of accelerated aging, the product has passed all tests, so it can be guaranteed that the product can be used normally within five years, and the shelf life can reach five years
Key Metrics
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 28, 2024
Ningbo Caremed Medical Products Co., Ltd. % Kyra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, China
Re: K242622
Trade/Device Name: Sterile Lancets for Single Use Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL Dated: August 27, 2024 Received: September 3, 2024
Dear Kyra Kang:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.10.28 15:36:30 -04'00'
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
3
Indications for Use
510(k) Number (if known) K242622
Device Name Sterile Lancets for Single Use
Indications for Use (Describe) Lancet is intended for capillary blood sampling.
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)
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4
K242622
510(k) Summary
l. Submitter
Ningbo Caremed Medical Products Co., Ltd. No.79 Jiutang Road, Hangzhou Bay New Zone, Ningbo, China
Preparation date: October 24, 2024.
Contact person: Ms. Cen Wei Position: General Manager Tel.: +86-574-58582551 E-mail: Wei-cen@caremed-nb.com
Submission Correspondent
Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com
II. Proposed Device
| Device Trade Name: | Sterile Lancets for Single Use |
|---|---|
| Common name: | Blood Lancets |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | QRK |
| Review Panel: | General & Plastic Surgery |
III. Predicate Devices
| 510(k) Number: | K220475 |
|---|---|
| Trade name: | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HHXVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HHXXIII-T, HH-XXIV-T) |
| Common name: | Blood Lancets |
| Classification: | Class II |
| Product Code: | QRL,QRK |
| Manufacturer | Tianjin Huahong Technology Co., Ltd. |
5
IV. Device description
The Sterile Lancets for Single Use is intended for capillary blood sampling.
The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only.
The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites.
The shelf-life of the product is 5 years.
V. Indication for use
The Sterile Lancets for Single Use is intended for capillary blood sampling.
VI. Comparison of technological characteristics with the predicate devices
| Character
istics | Proposed device | Predicate device
(K220475) | Discussio
n |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Manufactu
rer | Ningbo Caremed Medical
Products Co., Ltd. | Tianjin Huahong Technology
Co., Ltd. | / |
| Product
name | Sterile Lancets for Single Use | Lancet | / |
| Product
code | QRK | QRL,QRK | Same |
| Regulation
No. | 21 CFR § 878.4850 | 21 CFR § 878.4850 | Same |
| Class | II | II | Same |
| Prescriptio
n/
over-the-
cou
nter use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indication
for
use | The Sterile Lancets for Single
Use is intended for capillary
blood sampling. | It is intended for capillary
blood sampling | Same |
| Applicable | Healthcare professional or | Healthcare professional or | Same |
| user | lay person | lay person | |
| Reuse
durability | Single use | Single use | Same |
| Sterilizatio
n
method
and
SAL | Sterilized by Radiation
SAL=10-6 | Sterilized by Radiation
SAL=10-6 | Same |
| Manufactu
ring
aspects | For the Lancet, stainless
steel needle is fed into an
injection molding machine to
over-mold plastic material
(polyethylene (PE) and
Color master batch) forming
a body and cap, encapsulating
the stainless
steel needles. | For the Lancet, stainless
steel needle is fed into an
injection molding machine to
over-mold plastic material
(polyethylene (PE) and
Ethylene Vinyl Acetate (EVA)
and calcium powder) forming
a body and cap,
encapsulating the stainless
steel needles. | Same |
| Design
and
Functionali
ty
aspects | The Lancet comprises a
stainless steel needle
encapsulated with a plastic
body and cap, the cap is
twisted off to expose the
needle for use. | The Lancet comprises a
stainless steel needle
encapsulated with a plastic
body and cap, the cap is
twisted off to expose the
needle for use. | Same |
| Needle
length
range | $3.2\pm0.3$ mm | $3.2\pm0.3$ mm (Model: IA、
IB、
IC、ID、IE、IK、IL、IM、
IIA、
IIB、III、VI)
$2.1\pm0.3$ mm (Model : V) | Same |
| Gauge
range | 18G, 19G, 20G, 21G, 22G,
23G, 24G, 25G, 26G, 27G,
28G, 29G, 30G, 31G, 32G,
33G, 34G | $1.50\pm0.02$ mm (16G)
$1.20\pm0.01$ mm (18G)
$1.07\pm0.01$ mm (19G)
$0.91\pm0.01$ mm (20G) | Similar 1 |
| | | 0.72±0.01mm (22G)
0.64±0.01mm (23G)
0.57±0.01mm (24G)
0.51±0.01mm (25G)
0.46±0.01mm (26G)
0.41±0.01mm (27G)
0.36±0.01mm (28G)
0.34±0.01mm (29G)
0.31±0.01mm (30G)
0.26±0.01mm (31G)
0.24±0.01mm (32G)
0.21±0.01mm (33G)
0.19±0.01mm (34G) | |
| Shelf-life | 5 years | 5 years | Same |
| Materials
of
parts in
contact
with
human
body | Needle: Stainless steel
Needle holder (Main body &
Protective cap): PE&Color
master batch | The Lancet has a needle that
is made of stainless steel
and silicone oil. The body
and cap are made of
polyethylene (PE) and
Ethylene Vinyl Acetate (EVA)
and calcium powder. | Similar 2 |
| Biocompat
ibility | Conforms to the
requirements of ISO 10993
series standards. | Conforms to the
requirements of ISO 10993
series standards. | Same |
| Label/Lab
eling | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | Same |
Table 5.2-1 General Comparison of Sterile Lancets for Single Use
6
7
Similar 1- Gauge range
The gauge range of proposed device can be covered by predicate device, all performance has been tested, this difference will not raise any issues in safety and effectiveness
Similar 2 – Materials of parts in contact with human body
Biocompatibility of the Sterile Lancets for Single Use was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1", this difference will not raise any issues in safety and effectiveness.
8
VII. Non-Clinical Testing
Performance Testing
Performance testing is conducted according to Inspection Specification, the test sample has undergone accelerated aging for 5.5 years.
Tested the following projects : Appearance, Dimension, Firmness of needle and main body, Puncture Performance, Matching, Launch Performance, Bacterial endotoxin, Sterilization
Biocompatibility testing
Biocompatibility of the Sterile Lancets for Single Use was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1" The following testing was conducted:
- A Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Sensitization ISO 10993-10:2021 Biological evaluation of medical devices Part 10: A Tests for skin sensitization
-
Irritation ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Acute Systemic ISO 10993-23:2021 Biological evaluation of medical devices Part 23: > Tests for irritation
- Pyrogenicity ISO 10993-11:2017 Biological evaluation of medical devices Part 11: A Tests for systemic toxicity
Sterility and Shelf -life
After five years of accelerated aging, the product has passed all tests, so it can be guaranteed that the product can be used normally within five years, and the shelf life can reach five years
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated
9
K242622
device. Accordingly, the proposed device is substantially equivalent to the predicate device.