(190 days)
The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.
The provided text describes the 510(k) premarket notification for the "CareSens Pen Needle and Softip Pen Needle". It focuses on demonstrating substantial equivalence to a predicate device and a reference device, primarily through bench testing and biocompatibility assessments, rather than human clinical studies involving AI.
Therefore, many of the requested categories related to medical AI device studies, such as sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training, are not applicable or cannot be extracted from this document as the device in question is a physical medical needle, not an AI device.
Here's the information that can be extracted related to acceptance criteria and performance, as appropriate for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Performance Bench Tests (ISO 11608-2:2012) | ||
| Dimension testing | ISO 11608-2:2012 (4.2 Dimensions / 4.2.1 General / 4.2.2 Dimensions for needles), meets requirements | Meets requirements |
| Flow rate testing | ISO 11608-2:2012 (4.3 Determination of flow rate through the needle), meets requirements | Meets requirements |
| Bond between hub and needle tube testing | ISO 11608-2:2012 (4.4 Bond between hub and needle tube), meets requirements | Meets requirements |
| Needle point freedom from defects lubrication test | ISO 11608-2:2012 (4.5 Needle point / 4.6 Freedom from defects / 4.7 Lubrication), meets requirements | Meets requirements |
| Dislocation of measuring point at patient end | ISO 11608-2:2012 (4.8 Dislocation of measuring point at patient end), meets requirements | Meets requirements |
| Compatibility of needles and injector system test / Ease of assembly and disassembly | ISO 11608-2:2012 (4.9 Determination of functional compatibility with needle-based injection systems / 4.10 Ease of assembly and disassembly), meets requirements | Meets requirements |
| Biocompatibility Tests (ISO 10993) | ||
| Cytotoxicity test | ISO 10993-5, Tests for in vitro Cytotoxicity, Test on extracts | Non-Cytotoxic |
| Intracutaneous (Intradermal) Reactivity Test | ISO 10993-10, Intracutaneous(Intradermal) reactivity test | Negligible |
| Sensitization Test (Guinea pig maximization test) | ISO 10993-10, Sensitization(Guinea pig maximization test) | Weak sensitizer |
| Acute systemic toxicity test | ISO 10993-11, Acute systemic toxicity | Non-toxic |
| Pyrogen test | ISO 10993-11, USP Rabbit Pyrogen Test | Non-pyrogenic |
| Haemolysis test | ISO 10993-4, Haemolysis testing-general considerations | Non-hemolytic |
| Sterilization Tests | ||
| Packaging | Packaging should keep clean from microorganism and not be broken before use; needle packed one by one. | PASS |
| Sterility Test-Direct inoculation | The Korean pharmacopoeia Tenth edition (same as USP 25<71> sterility test) | PASS |
| Ethylene oxide sterilization residuals | ISO 10993-7: EO ≤4 mg first 24 hrs and ECH ≤9 mg first 24 hrs for limited exposure (<24 hours) | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for each bench test, biocompatibility test, and sterilization test are not provided in the document. The document states that tests were "conducted" and "results demonstrate," implying samples were used as per the standards, but quantities are absent.
- Data Provenance: Not explicitly stated for specific test data, but the manufacturer (YidoBio Inc.) is from Korea, suggesting studies were likely conducted there or by affiliated labs. The document is for an FDA 510(k) submission, indicating adherence to US regulatory standards. The studies described are prospective physical property and biological evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device (needle), not an AI diagnostic device. Ground truth for its performance is established by objective measurements against international standards (ISO standards, pharmacopoeia) and laboratory tests, not by expert human interpretation of data.
4. Adjudication method for the test set
- Not Applicable. As above, the performance is measured objectively against predefined standards, not through consensus or adjudication of human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For performance (dimensions, flow rate, bond, etc.): Objective measurements against defined ISO 11608-2 specifications.
- For biocompatibility: Laboratory test results against ISO 10993 standards.
- For sterility: Laboratory test results against compendial methods (Korean Pharmacopoeia/USP) and ISO 11135 for sterilization validation.
8. The sample size for the training set
- Not Applicable. This is not an AI device, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI device, the concept of a training set and its ground truth establishment does not apply.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
Yidobio Inc. Kyung Hee Yoon Excutive Director #3-1, 59-12, Dong-gil, Hyangnam-eup, Hwaseong-si Gyeonggi-do 18624 KOREA
Re: K160575
Trade/Device Name: CareSens Pen Needle and Softip Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 29, 2016 Received: August 10, 2016
Dear Kyung Hee Yoon:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160575
Device Name
CareSens Pen Needle and Softip Pen Needle
Indications for Use (Describe)
The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
| 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) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo for YIDOBIO. The logo consists of two stylized letters, 'O' and 'B', intertwined together in a calligraphic style. Below the letters, the word "YIDOBIO" is written in a simple, sans-serif font. The color of the logo and the text is a muted gray.
510(k) SUMMARY – K160575
A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
| 1. Prepared by: | Joon Ho JungRegulatory Affairsi-SENS, Inc.Tel. +82-02-910-0453Fax. +82-02-942-2514 |
|---|---|
| 2. Prepared for: | Owner/OperatorYidoBio Inc.59-12, Dongo4-gil, Hyangnam-eupHwaseong-si, Gyeonggi-do |
| 3. Contact person: | Kyung Hee YoonExecutive DirectorYidoBio Inc.59-12, Dongo4-gil, Hyangnam-eupHwaseong-si, Hyangnam-eup |
| 4. Date Prepared: | February 1, 2016 |
| 5. Subject Device: | |
| Proprietary Name: | CareSens Pen Needle and Softip Pen Needle |
| Common Name: | Insulin Pen Needle |
| Regulation Name: | Needle, Hypodermic, Single Lumen |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Regulatory Class: | Class II |
| 6. Device Description |
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Image /page/4/Picture/0 description: The image shows a stylized monogram of the letters 'O' and 'B' in a flowing, intertwined design. The letters are rendered in a muted gray color, giving them a soft and elegant appearance. The design is intricate, with the curves of the letters overlapping and connecting to create a unified and visually appealing emblem. The overall impression is one of sophistication and classic style.
YIDOBIO
CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.
7. Predicate Device
The legally marketed device(s) to which substantial equivalence is claimed is/are:
- K063466 TopFine® Insulin Pen, ● Manufactured by Daejin Tech Medical Manufacturing Co., Ltd., Korea
| Regulation Name: | Needle, Hypodermic, Single Lumen |
|---|---|
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Regulatory Class: | Class II |
7.1 Reference device
- K 131358 BD 31G and 32G Extra Thin Wall (XTM) Pen Needles with PentaPoint, manufactured by Becton, Dickinson and Company, New Jersey.
| Regulation Name: | Needle, Hypodermic, Single Lumen |
|---|---|
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Regulatory Class: | Class II |
8. Reason for 510(K) Submission
This 510(k) is submitted to demonstrate substantial equivalence to the predicate device. CareSens Pen Needle and Softip Pen Needle. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.
The specifications of the product are as follows:
| No. | Gauge (Outer diameter of Needle) | Length of needle | Weight |
|---|---|---|---|
| ----- | ---------------------------------- | ------------------ | -------- |
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Image /page/5/Picture/0 description: The image shows a stylized monogram consisting of the letters 'O' and 'B'. The letters are intertwined and feature elegant, flowing lines with flourishes, giving the monogram a sophisticated and decorative appearance. The color of the monogram is a muted gray, which adds to its subtle and refined aesthetic. The overall design suggests a logo or emblem, possibly for a brand or personal use.
| (mm) l | (g) | ||
|---|---|---|---|
| 1 | 30G (0.298mm ~ 0.320mm) | 8mm(5/16") | |
| 2 | 31G (0.254mm ~ 0.267mm) | 5mm(3/16") | |
| 3 | 6mm(1/4") | ||
| 4 | 8mm(5/16") | 1.22 | |
| 5 | 32G (0.229mm ~ 0.241mm) | 4mm(5/32") | |
| 6 | 5mm(3/16") | ||
| 7 | 6mm(1/4") | ||
| 8 | 33G (0.204mm ~ 0.215mm) | 4mm(5/32") |
9. Indication For Use
The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
10. Technological Characteristics
Comparison with Predicate Device (K063466 TopFine Insulin Pen Needle)
The subject device, CareSens Pen Needle and Softip Pen Needle are similar in its intended use, principle of operation, design construction, sizes, material, and sterilization method. The subject device and predicate device both completed biocompatibility and sterility testing with similar results.
The subject device and the predicate device are classified under 21 CFR 880.5570. which states: "A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." The proposed device and the predicate device use statements similar in that they both are used with pen injector devices for subcutaneous injection of fluids, including insulin. The subject device is also used to inject exenatide.
| Similarities between the Subject Devices and the Predicate Device | ||
|---|---|---|
| Item | Topfine Insulin Pen Needle(K063466, Predicate device) | CareSens Pen Needle andSoftip Pen Needle(subject device) |
| Intended use | Intended for subcutaneousinjection of insulin in thetreatment of diabetes. | Intended for use with peninjector devices forsubcutaneous injection of fluids,including insulin and exenatide. |
| Operation Principle | To be used with peninjectors/Single use | Same |
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Image /page/6/Picture/0 description: The image shows a stylized monogram of the letters 'O' and 'B' intertwined. The letters are rendered in a soft gray color and feature flowing, calligraphic lines. The 'O' is positioned to the left and slightly above the 'B', with the curves of the letters overlapping to create a unified design. The overall effect is elegant and decorative.
YIDOBIO
| Design/Construction | • Needle assembly (cannula,needle hub, protector cap) | Same |
|---|---|---|
| Material | • Outer cap - Polypropylene• Inner Cap - Polyethylene• Needle – 304 Stainless• Needle Silicone -Polydimethylsiloxane• Needle Hub – Polypropylene | Same |
| Gauges/length of needle | 30G 8mm, 31G 5mm, 31G 6mm,31G 8mm, 32G 4mm, 32G 5mm,32G 6mm, 33G 4mm | Same |
| Sterilization | EO Gas sterilization | Same |
| Biocompatibility | In accordance to ISO 10993 | Same |
Comparison with the Reference Device (K131358 BD 31G and 32G Extra Thin Wall (XTM) Pen Needles with PentaPoint)
The reference device is used in comparison for performance bench testing in accordance to ISO 11608-2. The reference device is also indicated for use of the injection of both insulin and exenatide.
| Similarities between the Subject Devices and the Reference Device | ||
|---|---|---|
| Item | CareSens Pen Needle andSoftip Pen Needle(subject device) | BD 31G and 32G ExtraThin Wall (XTM) PenNeedles with PentaPoint(K131358, Reference Device) |
| Intended use | CareSens Pen Needle and SoftipPen Needle are Intended for usewith pen injector devices forsubcutaneous injection of fluids,including insulin and exenatide. | BD Pen Needle is intendedfor use with pen injectordevice for subcutaneousinjection of drugs, includinginsulin and exenatide. |
| Operation Principle | To be used with peninjectors/Single use | Same |
| Design/Construction | Needle assembly (cannula,needle hub, protector cap) | Same |
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Image /page/7/Picture/0 description: The image shows a stylized logo with intertwined letters, likely a monogram. The letters appear to be 'C' and 'B', rendered in a flowing, calligraphic style. Below the monogram, there is some text, but it is too blurry to read. The logo is presented in a light gray color against a white background.
| Material | • Outer cap - Polypropylene• Inner Cap - Polyethylene• Needle – 304 Stainless• Needle Silicone –Polydimethylsiloxane• Needle Hub – Polypropylene | • Outer cap – Unknown plastic• Inner Cap – Unknown plastic• Needle - Stainless steel• Needle Silicone – Unknown• Needle Hub – Unknownplastic |
|---|---|---|
| Sterilization | EO Gas sterilization | Gamma irradiation |
| Performance Bench | ISO 11608-2 | ISO 11608-2 |
Bench tests relating to the performance of CareSens Pen Needle and Softip Pen Needle were conducted. Testing to voluntary standards ISO 11608-2 provides additional evidence that the performance of CareSens Pen Needle and Softip Pen Needle demonstrated equivalent performance to the Reference Device.
11. Summary of performance tests
| Dimension testing | ISO11608-2:2012 (4.2 Dimensions / 4.2.1 General / 4.2.2 Dimensions for needles), meets requirements |
|---|---|
| Flow rate testing | ISO11608-2:2012 (4.3 Determination of flow rate through the needle), meets requirements |
| Bond between hub and needle tube testing | ISO11608-2:2012 (4.4 Bond between hub and needle tube), meets requirements |
| Needle point freedom from defects lubrication test | ISO11608-2:2012 (4.5 Needle point / 4.6 Freedom from defects / 4.7 Lubrication), meets requirements |
| Dislocation of measuring point at patient end | ISO11608-2:2012 (4.8 Dislocation of measuring point at patient end), meets requirements |
| Compatibility of needles and injector system test / Ease of assembly and disassembly. | ISO11608-2:2012 (4.9 Determination of functional compatibility with needle-based injection systems / 4.10 Ease of assembly and disassembly), meets requirements |
Biocompatibility
Biocompatibility testing of the subject device, Softip Pen Needle and CareSens Pen Needle, were conducted so ensure no physical harm on the human skin. Results of the testing demonstrate that the device is biocompatible. Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained. Results of the testing demonstrate that the device is biocompatible.
| No. | Test Items | Test Method | Result |
|---|---|---|---|
| 1 | Cytotoxicity test | ISO 10993-5, Tests for in vitro Cytotoxicity, | Non- |
| Test on extracts | Cytotoxic |
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Image /page/8/Picture/0 description: The image shows a stylized monogram consisting of the letters 'O' and 'B' intertwined. The letters are rendered in a flowing, calligraphic style with delicate curves and flourishes. The color of the monogram is a muted gray, giving it a soft and elegant appearance.
YIDOBIO
| 2 | Intracutaneous(Intradermal)Reactivity Test | ISO 10993-10,Intracutaneous(Intradermal) reactivity test | Negligible |
|---|---|---|---|
| 3 | SensitizationTest(Guinea pigmaximization test) | ISO 10993-10, Sensitization(Guinea pigmaximization test) | Weaksensitizer |
| 4 | Acute systemictoxicity test | ISO 10993-11, Acute systemic toxicity | Non-toxic |
| 5 | Pyrogen test | ISO 10993-11, USP Rabbit Pyrogen Test | Non-pyrogenic |
| 6 | Haemolysis test | ISO 10993-4, Haemolysis testing-generalconsiderations | Non-hemolytic |
Sterilization
EO gas sterilization method is utilized for assuring sterility of the subject device, Softip Pen Needle and CareSens Pen Needle. The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135. The sterilization validation has provided a Sterility Assurance Level (SAL) of 10°.
| No. | Test items | Test Method | Result |
|---|---|---|---|
| 1 | Packaging | The case of injection or outer package should keep cleanfrom microorganism and should not be broken beforeuse. Also needle should be packed one by one. | PASS |
| 2 | Sterility Test-Directinoculation | The Korean pharmacopoeia Tenth edition(same as the FDA recognized consensus standard"USP 25<71> sterility test" are the same in testprotocol.) | PASS |
| 3 | Ethylene oxidesterilization residuals | If the product is sterilized by EO gas, it should be testedin accordance with ISO 10993-7, Ethylene oxidesterilization residuals. The Sterilant Residual Limits perISO 10993-7 for a limited exposure (<24 hours) deviceis as follows: EO ≤4 mg first 24 hrs and ECH ≤9 mgfirst 24 hrs. | PASS |
12. Conclusion:
Based on the submitted information in this premarket notification, the subject devices are substantially equivalent to the predicate device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).