(227 days)
The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations. The Zip 4 Skin Closure Device may be sold direct to consumers (OTC).
The Zip® 4 Skin Closure Device is a single-use non-invasive skin closure device. A single Zip 4 device may be used to close wounds up to 4 cm (1.5 inches) in length from minor cuts or minor lacerations. The device is applied to clean, dry skin prior to skin closure, remains on the skin during wound healing, and may be removed by lifting one edge and peeling the device from the skin. The device is made of polymeric materials and utilizes a non-latex, pressure sensitive skin adhesive. The device contents are provided sterile in an intact and unopened package.
This document is a 510(k) Pre-market Notification for the Zip 4 Skin Closure Device. It focuses on demonstrating substantial equivalence to a predicate device rather than on clinical performance for novel AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and performance against a ground truth is not directly applicable or available in this document.
However, I can extract the non-clinical performance data and the conclusion that supports the device's substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing conducted to demonstrate compliance with product requirements, but it does not specify quantitative acceptance criteria or corresponding reported performance metrics in a table format that typically applies to AI/ML model evaluations (e.g., sensitivity, specificity, AUC). Instead, it lists the types of tests performed and the standards met.
| Testing Category | Description of Tests / Standards Met |
|---|---|
| Non-Clinical Performance | Performance testing (dimensional, mechanical, human wear test, biocompatibility, sterility, packaging/shelf life) was conducted to demonstrate compliance with product requirements. |
| Standards Used | - ISO 10993-1:2009 (Cor:2010), Biological evaluation of medical devices – Part 1: Evaluation and testing- ISO 11137-2:2013, Sterilization Of Health Care Products - Radiation - Part 2: Establishing The Sterilization Dose- ASTM D 4169-14, Standard Practice for Performance Testing of Shipping Containers and Systems- ASTM F 2096-11: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)- IEC/EN 62366: 2014, Medical Devices - Application Of Usability Engineering To Medical Devices |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document pertains to a medical device (skin closure device), not an AI/ML algorithm. Therefore, there is no "test set" in the context of an AI/ML model for data evaluation. The "human wear test" mentioned in the non-clinical performance data would involve human subjects, but the sample size and specific details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is not an AI/ML device, the concept of establishing ground truth by experts for a test set is not relevant.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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:
- No. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used:
- Not Applicable / Indirect. For a physical device, "ground truth" would relate to its physical properties, biocompatibility, and functional performance as determined by established engineering standards, biological assessments, and usability. The "ground truth" is established through adherence to the listed ISO and ASTM standards, which provide validated methods for testing these aspects.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary regarding the device's "study" and "acceptance criteria":
The "study" for the Zip 4 Skin Closure Device was a series of non-clinical performance tests designed to show that the device meets its product requirements and complies with relevant international and national standards.
The acceptance criteria are implicitly defined by compliance with these standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization dose, ASTM D 4169 for packaging, ASTM F 2096 for leak detection, and IEC/EN 62366 for usability). The document states that performance testing, including dimensional, mechanical, and human wear tests, was "conducted on the subject Zip 4 Skin Closure Device to demonstrate compliance with the product requirements specification either by design analysis or functional testing."
The conclusion states, "The successful completion of the performance testing further supports the subject Zip 4 Skin Closer Device's substantial equivalence to the predicate device. The usability testing that was successfully performed shows that the proposed device can be marketed for over-the-counter use. No issues of safety or effectiveness are raised by the Zip 4 Skin Closure Device." This indicates that the device met the implicit acceptance criteria by passing these non-clinical tests.
Important Note: This 510(k) summary is for a traditional medical device and explicitly states, "No clinical testing was deemed necessary to support the substantial equivalence." Therefore, it does not contain the types of AI/ML-specific performance metrics or study designs typically requested for AI/ML devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
Zipline Medical, Inc. % Nancy Kaiser Regulatory Consultant 88 South Milton Avenue Campbell, California 95008
Re: K170003
Trade/Device Name: Zip 4 Skin Closure Device Regulation Number: 21 CFR 880.5240 Regulation Name: Medical Adhesive Tape and Adhesive Bandage Regulatory Class: Class I Product Code: PYO Dated: July 20, 2017 Received: July 21, 2017
Dear Nancy Kaiser:
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.
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 devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. 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
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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170003
Device Name Zip 4 Skin Closure Device
| Indications for Use (Describe) |
|---|
| The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations. |
| 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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K170003
Premarket Notification [510(k)] Summary
| Submitter'sName andAddress | ZipLine Medical, Inc.747 Camden Ave., Suite ACampbell, CA 95008 |
|---|---|
| Contact NameandInformation | Name: Nancy KaiserTitle: Regulatory ConsultantTel: (408) 431.5858Fax: N/AE-mail: nancykaiser01@gmail.com |
| Date Prepared | December 30, 2016 |
| Trade Name | Zip® 4 Skin Closure Device |
| CommonName | Skin Closure Device |
| ClassificationName | Tape and Bandage, Adhesive, Adjustable Closing Mechanism,OTC Use (Product Code PYO); Class I Non-Exempt per 21 CFR880.5240 |
| PredicateDevices | 3M Company Steri-Strip Skin Closure Device, legally marketed aspre-amendment device (PA Reference Number: 2016-PA-0005) |
| DeviceDescription | The Zip® 4 Skin Closure Device is a single-use non-invasive skinclosure device. A single Zip 4 device may be used to closewounds up to 4 cm (1.5 inches) in length from minor cuts or minorlacerations. The device is applied to clean, dry skin prior to skinclosure, remains on the skin during wound healing, and may beremoved by lifting one edge and peeling the device from the skin.The device is made of polymeric materials and utilizes a non-latex, pressure sensitive skin adhesive. The device contents areprovided sterile in an intact and unopened package. |
| Intended Use/Indications forUse | The Zip 4 Skin Closure Device is indicated for skin closure ofminor lacerations. The Zip 4 Skin Closure Device may be solddirect to consumers (OTC). |
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Device Technological Characteristics and Comparison to Predicate Device
The Zip 4 device is made of two pressure-sensitive adhesive patches comprising the Adhesive Base, which are connected to each other by an Adjustable Closing Mechanism. The wound is closed by compressing the skin together with fingers and then pulling the adjustable latching member tight.
The 3M™ Steri-Strip™ is made of porous non-woven material reinforced with filaments for strength. The wound is closed by compressing skin with fingers or forceps and placing the strips across the wound. Steri-Strips are provided sterile in individual packs. Multiple strips can be placed next to each other, 3mm apart, to close larger wounds.
Both the Steri-Strip and Zip 4 devices are tape-based wound closure devices that do not pierce the skin but hold the skin together using tension across the wound. A side-by-side comparison of the subject device to the predicate device follows:
| Subject Device: | Predicate Device: | |
|---|---|---|
| Device Attribute | ZipLine Medical,Inc.Zip 4 Skin ClosureDevice | 3M CorporationSteri-Strip SkinClosure Device(Legally Marketedas PreamendmentDevice) |
| DeviceClassificationRegulation Numberand RegulationDescription | Tape andBandage,Adhesive,Adjustable ClosingMechanism, OTCUse (Product CodePYO); Class I Non-Exempt per 21CFR 880.5240 | Class I Exempt |
| ClassificationProduct Code | PYO | KGX |
| Mechanism ofAction | Tape-based woundclosure device thatdoes not piercetissue. | Same |
| Intended/Indications for Use | The Zip 4 SkinClosure Device is | Steri-Strip skinclosures are |
510(k) Summary - Device Comparison
Confidential and Proprietary to ZipLine Medical, Inc.
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| indicated for skinclosure of minorlacerations. . | indicated for use as askin closure device inthe treatment oflacerations andsurgical incisions.Steri-Strip skinclosures may also beused in conjunctionswith skin sutures andstaples or after theirremoval for woundsupport. | |
|---|---|---|
| Mechanism ofAction | Tape based woundclosure device thatdoes not piercetissue. | Same |
| Size | Closes wounds up to4 cm (1.5 inches) inlength. | Steri-Strips areavailable in varioussizes (e.g., 38 mm to125 mm in length). |
| Components | Biocompatiblepolyurethane stripscoated with adhesiveand polymer strapswith ratcheting locks. | Biocompatibleporous non-wovenmaterial reinforcedwith filaments forstrength and coatedwith a hypoallergenicadhesive. |
| How Supplied | Sterile, for single useonly | Same |
| Biocompatible | Yes | Same |
| Sterilization Method | (Electron-beam)Radiation | Radiation |
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| Non-ClinicalPerformanceData | Performance testing was conducted on the subject Zip 4 SkinClosure Device to demonstrate compliance with the productrequirements specification either by design analysis or functionaltesting. The following product requirements are supported:dimensional and mechanical tests, through simulated use as wellas a human wear test, biocompatibility, sterility, and packaging /shelf life. The following standards were used for testing: |
|---|---|
| • ISO 10993-1:2009 (Cor:2010), Biological evaluation ofmedical devices – Part 1: Evaluation and testing | |
| • ISO 11137-2:2013, Sterilization Of Health Care Products -Radiation - Part 2: Establishing The Sterilization Dose | |
| • ASTM D 4169-14, Standard Practice for PerformanceTesting of Shipping Containers and Systems | |
| • ASTM F 2096-11: Standard Test Method for DetectingGross Leaks in Packaging by Internal Pressurization(Bubble Test) | |
| • IEC/EN 62366: 2014, Medical Devices - Application OfUsability Engineering To Medical Devices | |
| ClinicalPerformanceData | No clinical testing was deemed necessary to support thesubstantial equivalence. |
| Conclusion | This 510(k) notification for the Zip 4 Skin Close Device concludesthat the device is considered to be substantially equivalent to thelegally-marketed predicate device (as shown in the 510(k)Summary – Device Comparison Table). The successfulcompletion of the performance testing further supports the subjectZip 4 Skin Closer Device's substantial equivalence to the predicatedevice. The usability testing that was successfully performedshows that the proposed device can be marketed for over-the-counter use. No issues of safety or effectiveness are raised by theZip 4 Skin Closure Device. |
§ 880.5240 Medical adhesive tape and adhesive bandage.
(a)
Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.