Zip 4 Skin Closure Device

K170003 · Zipline Medical, Inc. · PYO · Aug 18, 2017 · General Hospital

Device Facts

• Record ID: K170003
• Device Name: Zip 4 Skin Closure Device
• Applicant: Zipline Medical, Inc.
• Product Code: PYO · General Hospital
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5240
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

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).

Device Story

Zip 4 Skin Closure Device is a single-use, non-invasive, tape-based wound closure device for minor lacerations up to 4 cm. Device consists of two pressure-sensitive adhesive patches connected by an adjustable ratcheting mechanism. Applied to clean, dry skin; wound closed by compressing skin edges and tightening the latching member. Remains on skin during healing; removed by peeling. Used in clinical or home settings (OTC); operated by clinicians or patients. Provides mechanical tension to hold skin edges together without piercing tissue. Benefits include non-invasive wound approximation, reducing need for sutures or staples in minor wounds.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including dimensional and mechanical tests, simulated use, human wear testing, biocompatibility, sterility, and packaging/shelf-life validation.

Technological Characteristics

Materials: Biocompatible polyurethane strips, pressure-sensitive adhesive, polymer straps with ratcheting locks. Principle: Tape-based mechanical tension. Form factor: Single-use adhesive patch with adjustable closing mechanism. Sterilization: Electron-beam radiation. Standards: ISO 10993-1:2009, ISO 11137-2:2013, ASTM D 4169-14, ASTM F 2096-11, IEC/EN 62366:2014.

Indications for Use

Indicated for skin closure of minor lacerations in patients requiring non-invasive wound closure.

Regulatory Classification

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.

Predicate Devices

• 3M Company Steri-Strip Skin Closure Device (2016-PA-0005)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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's<br>Name and<br>Address | ZipLine Medical, Inc.<br>747 Camden Ave., Suite A<br>Campbell, CA 95008 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and<br>Information | Name: Nancy Kaiser<br>Title: Regulatory Consultant<br>Tel: [phone]<br>Fax: N/A<br>E-mail: [e-mail] |
| Date Prepared | December 30, 2016 |
| Trade Name | Zip® 4 Skin Closure Device |
| Common<br>Name | Skin Closure Device |
| Classification<br>Name | Tape and Bandage, Adhesive, Adjustable Closing Mechanism,<br>OTC Use (Product Code PYO); Class I Non-Exempt per 21 CFR<br>880.5240 |
| Predicate<br>Devices | 3M Company Steri-Strip Skin Closure Device, legally marketed as<br>pre-amendment device (PA Reference Number: 2016-PA-0005) |
| Device<br>Description | The Zip® 4 Skin Closure Device is a single-use non-invasive skin<br>closure device. A single Zip 4 device may be used to close<br>wounds up to 4 cm (1.5 inches) in length from minor cuts or minor<br>lacerations. The device is applied to clean, dry skin prior to skin<br>closure, remains on the skin during wound healing, and may be<br>removed by lifting one edge and peeling the device from the skin.<br>The device is made of polymeric materials and utilizes a non-<br>latex, pressure sensitive skin adhesive. The device contents are<br>provided sterile in an intact and unopened package. |
| Intended Use/<br>Indications for<br>Use | The Zip 4 Skin Closure Device is indicated for skin closure of<br>minor lacerations. The Zip 4 Skin Closure Device may be sold<br>direct 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,<br>Inc.<br>Zip 4 Skin Closure<br>Device | 3M Corporation<br>Steri-Strip Skin<br>Closure Device<br>(Legally Marketed<br>as Preamendment<br>Device) |
| Device<br>Classification<br>Regulation Number<br>and Regulation<br>Description | Tape and<br>Bandage,<br>Adhesive,<br>Adjustable Closing<br>Mechanism, OTC<br>Use (Product Code<br>PYO); Class I Non-<br>Exempt per 21<br>CFR 880.5240 | Class I Exempt |
| Classification<br>Product Code | PYO | KGX |
| Mechanism of<br>Action | Tape-based wound<br>closure device that<br>does not pierce<br>tissue. | Same |
| Intended/<br>Indications for Use | The Zip 4 Skin<br>Closure Device is | Steri-Strip skin<br>closures are |

### 510(k) Summary - Device Comparison

Confidential and Proprietary to ZipLine Medical, Inc.

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| | indicated for skin<br>closure of minor<br>lacerations. . | indicated for use as a<br>skin closure device in<br>the treatment of<br>lacerations and<br>surgical incisions.<br>Steri-Strip skin<br>closures may also be<br>used in conjunctions<br>with skin sutures and<br>staples or after their<br>removal for wound<br>support. |
|------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism of<br>Action | Tape based wound<br>closure device that<br>does not pierce<br>tissue. | Same |
| Size | Closes wounds up to<br>4 cm (1.5 inches) in<br>length. | Steri-Strips are<br>available in various<br>sizes (e.g., 38 mm to<br>125 mm in length). |
| Components | Biocompatible<br>polyurethane strips<br>coated with adhesive<br>and polymer straps<br>with ratcheting locks. | Biocompatible<br>porous non-woven<br>material reinforced<br>with filaments for<br>strength and coated<br>with a hypoallergenic<br>adhesive. |
| How Supplied | Sterile, for single use<br>only | Same |
| Biocompatible | Yes | Same |
| Sterilization Method | (Electron-beam)<br>Radiation | Radiation |

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| Non-Clinical<br>Performance<br>Data | Performance testing was conducted on the subject Zip 4 Skin<br>Closure Device to demonstrate compliance with the product<br>requirements specification either by design analysis or functional<br>testing. The following product requirements are supported:<br>dimensional and mechanical tests, through simulated use as well<br>as a human wear test, biocompatibility, sterility, and packaging /<br>shelf life. The following standards were used for testing: |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • ISO 10993-1:2009 (Cor:2010), Biological evaluation of<br>medical devices – Part 1: Evaluation and testing |
| | • ISO 11137-2:2013, Sterilization Of Health Care Products -<br>Radiation - Part 2: Establishing The Sterilization Dose |
| | • ASTM D 4169-14, Standard Practice for Performance<br>Testing of Shipping Containers and Systems |
| | • ASTM F 2096-11: Standard Test Method for Detecting<br>Gross Leaks in Packaging by Internal Pressurization<br>(Bubble Test) |
| | • IEC/EN 62366: 2014, Medical Devices - Application Of<br>Usability Engineering To Medical Devices |
| Clinical<br>Performance<br>Data | No clinical testing was deemed necessary to support the<br>substantial equivalence. |
| Conclusion | This 510(k) notification for the Zip 4 Skin Close Device concludes<br>that the device is considered to be substantially equivalent to the<br>legally-marketed predicate device (as shown in the 510(k)<br>Summary – Device Comparison Table). The successful<br>completion of the performance testing further supports the subject<br>Zip 4 Skin Closer Device's substantial equivalence to the predicate<br>device. The usability testing that was successfully performed<br>shows that the proposed device can be marketed for over-the-<br>counter use. No issues of safety or effectiveness are raised by the<br>Zip 4 Skin Closure Device. |