(227 days)
2016-PA-0005
Not Found
No
The device description and performance studies focus on mechanical and material properties for skin closure, with no mention of AI/ML algorithms or data processing.
No
The device is described as a skin closure device for minor lacerations and is sold over-the-counter, indicating it's for wound management rather than treating a disease or condition.
No
The device is described as a "skin closure device" intended for closing "minor lacerations." Its function is to approximate wound edges, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a physical, single-use, non-invasive skin closure device made of polymeric materials with adhesive, provided sterile. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "skin closure of minor lacerations." This is a physical action performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device applied to the skin for wound closure. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or screening.
The Zip 4 Skin Closure Device is a medical device used for wound closure, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes
PYO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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 following product requirements are supported: dimensional and mechanical tests, through simulated use as well as 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 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
No clinical testing was deemed necessary to support the substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
3M Company Steri-Strip Skin Closure Device, legally marketed as pre-amendment device (PA Reference Number: 2016-PA-0005)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation 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
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.
1
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
2
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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3
K170003
Premarket Notification [510(k)] Summary
| Submitter's
Name and
Address | ZipLine Medical, Inc.
747 Camden Ave., Suite A
Campbell, CA 95008 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Name: Nancy Kaiser
Title: Regulatory Consultant
Tel: (408) 431.5858
Fax: N/A
E-mail: nancykaiser01@gmail.com |
| Date Prepared | December 30, 2016 |
| Trade Name | Zip® 4 Skin Closure Device |
| Common
Name | Skin Closure Device |
| Classification
Name | Tape and Bandage, Adhesive, Adjustable Closing Mechanism,
OTC Use (Product Code PYO); Class I Non-Exempt per 21 CFR
880.5240 |
| Predicate
Devices | 3M Company Steri-Strip Skin Closure Device, legally marketed as
pre-amendment device (PA Reference Number: 2016-PA-0005) |
| Device
Description | 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. |
| Intended Use/
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). |
4
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 Closure | ||
| Device | 3M Corporation | |
| Steri-Strip Skin | ||
| Closure Device | ||
| (Legally Marketed | ||
| as Preamendment | ||
| Device) | ||
| Device | ||
| Classification | ||
| Regulation Number | ||
| and Regulation | ||
| Description | Tape and | |
| Bandage, | ||
| Adhesive, | ||
| Adjustable Closing | ||
| Mechanism, OTC | ||
| Use (Product Code | ||
| PYO); Class I Non- | ||
| Exempt per 21 | ||
| CFR 880.5240 | Class I Exempt | |
| Classification | ||
| Product Code | PYO | KGX |
| Mechanism of | ||
| Action | Tape-based wound | |
| closure device that | ||
| does not pierce | ||
| tissue. | Same | |
| Intended/ | ||
| Indications for Use | The Zip 4 Skin | |
| Closure Device is | Steri-Strip skin | |
| closures are |
510(k) Summary - Device Comparison
Confidential and Proprietary to ZipLine Medical, Inc.
5
| | indicated for skin
closure of minor
lacerations. . | indicated for use as a
skin closure device in
the treatment of
lacerations and
surgical incisions.
Steri-Strip skin
closures may also be
used in conjunctions
with skin sutures and
staples or after their
removal for wound
support. |
|------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism of
Action | Tape based wound
closure device that
does not pierce
tissue. | Same |
| Size | Closes wounds up to
4 cm (1.5 inches) in
length. | Steri-Strips are
available in various
sizes (e.g., 38 mm to
125 mm in length). |
| Components | Biocompatible
polyurethane strips
coated with adhesive
and polymer straps
with ratcheting locks. | Biocompatible
porous non-woven
material reinforced
with filaments for
strength and coated
with a hypoallergenic
adhesive. |
| How Supplied | Sterile, for single use
only | Same |
| Biocompatible | Yes | Same |
| Sterilization Method | (Electron-beam)
Radiation | Radiation |
6
| Non-Clinical
Performance
Data | Performance testing 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 following product requirements are supported:
dimensional and mechanical tests, through simulated use as well
as 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 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 |
| Clinical
Performance
Data | No clinical testing was deemed necessary to support the
substantial equivalence. |
| Conclusion | This 510(k) notification for the Zip 4 Skin Close Device concludes
that the device is considered to be substantially equivalent to the
legally-marketed predicate device (as shown in the 510(k)
Summary – Device Comparison Table). 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. |