EXICLIP EXCS-M

K070836 · Clevex, Inc. · MJG · Apr 20, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070836
• Device Name: EXICLIP EXCS-M
• Applicant: Clevex, Inc.
• Product Code: MJG · General, Plastic Surgery
• Decision Date: Apr 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.

Device Story

ExiClip™ EXCS-M is a single-use, disposable, manually operated device for skin lesion removal and wound closure. It integrates a blade for tissue excision and a delivery system for applying a non-absorbable stainless steel skin clip. Used in clinical settings, the device allows a clinician to excise a lesion and immediately close the wound site with the clip. The clip remains in place until the wound heals and must be removed by the clinician. The device provides a biopsy specimen for pathological analysis or simply removes the lesion. It benefits patients by combining excision and closure into a single procedure.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics, including retention force measurements and material composition.

Technological Characteristics

Single-use, disposable, manually powered device. Components include a stainless steel blade and a non-absorbable stainless steel skin clip. Operates via plastic deformation of the clip during application. Provided sterile.

Indications for Use

Indicated for patients requiring removal of skin lesions less than 6mm in diameter, with or without biopsy, where simultaneous wound closure is desired.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Shoney Scientific Disposable Punch Biopsy (Class I, 510(k) exempt)
• AutoClip® Applier; AutoClip® Wound Clip (Class I, 510(k) exempt)

Submission Summary (Full Text)

{0}------------------------------------------------

K070836

APP 9 6 3 311

510(k) CleveX Inc. ExiClip™ EXCS-M Page 32 of 33

5. 510(k) Summary

# Summary of Safety and Effectiveness for the ExiClip™ EXCS-M

## Date Prepared

March 21, 2007

## Sponsor

CleveX Inc. 1275 Kinnear Rd Columbus, OH 43212 [phone] Telephone: Facsimile: [phone] Email: [e-mail]

## Official Contact Person

Lena Sattler Orasi Consulting, LLC. 9996 Carrousel Ct. Loveland, OH 45140 Telephone: [phone] [phone] Facsimile: [e-mail] E-mail:

## Common/Usual Name

Device, Percutaneous Biopsy; Clip Applier; Removable Skin Clip

## Proprietary Names

ExiClip™ EXCS-M

## Classification Information

| Classification Name(s): | Device, Percutaneous Biopsy<br>Applier, Surgical Clip<br>Removable Skin Clip |
|-------------------------|------------------------------------------------------------------------------------------------|
| Medical Specialty: | General & Plastic Surgery |
| Device Class: | I (each of three) |
| Classification Panel: | General & Plastic Surgery Device Panel |
| Product Codes: | MJG – Device, Percutaneous Biopsy<br>GDO – Applier, Surgical Clip<br>FZQ - Removable Skin Clip |

CleveX Inc. Proprietary and Confidential Information 1275 Kinnear Rd, Columbus, OH 43212 March 21, 2007

{1}------------------------------------------------

70g.36

510(k) CleveX Inc. ExiClip™ EXCS-M Page 33 of 33

## Identification of a Legally Marketed Predicate Device

| Trade/Device Name: | Shoney Scientific Disposable Punch<br>Biopsy |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Premarket Notification number:<br>FDA Product Code: | NONE - Class I; 510(k) exempt<br>MJG - Device, Percutaneous Biopsy |
| Trade/Device Name: | AutoClip® Applier; AutoClip® Wound<br>Clip (Device: Skin Clip w/ Applicator |
| 510(k) Premarket Notification number:<br>FDA Product Code: | NONE - Class I; 510(k) exempt<br>GDO - Applier, Surgical Clip<br>FZQ - Removable Skin Clip |

#### General Description

The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.

#### Indications for Use

The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.

## Summary of Technological Characteristics

The ExiClip™ EXCS-M device is substantially equivalent to the Shoney Scientific punch biopsy in that both devices provide a tissue sample suitable for pathology analysis or remove skin lesions. Both devices are manually powered. Both devices utilize stainless steel blades. Both devices are provided sterile. Both devices have the same intended use - removal of skin lesions and/or provide a tissue sample for pathological analysis.

The ExiClip™ EXCS-M device is substantially equivalent to the AutoClip® Wound Clip with Applier Device (Skin Clip) in that both devices deploy a skin clip for wound closure by activation by plastic deformation of the stainless steel clips via the use of an applier. Both clip appliers have the same intended use which is to apply a surgical clip for wound closure.

The ExiClip™ EXCS-M skin clip has been found to have a comparable retention force to the AutoClip® Wound Clip. Both devices utilize a clip made of stainless steel. Both devices are manually powered. Both devices have the same intended use which is a non-absorbable skin clip for wound closure.

CleveX Inc. Proprietary and Confidential Information 1275 Kinnear Rd. Columbus. OH 43212 March 21, 2007

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle with three stylized lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cleve X, Incorporated % Orasi Consulting, LLC Ms. Lena Sattler 9996 Carrousel Court Loveland, Ohio 45140

APR 2 0 2007

Re: K070836 Trade/Device Name: ExiClip™ EXCS-M Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: MJG, GDO, FZO Dated: March 22, 2007 Received: March 27, 2007

Dear Ms. Sattler:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

Page 2 -- Ms. Lena Sattler

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| | 7. Indications for Use Statement |
|---------------------------|----------------------------------|
| 510(k) Number (if known): | K070836 |
| Device Name: | ExiClip™ EXCS-M |

Indications for Use:
The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| Prescription Use | X |
|----------------------------|---------------|
| (Per 21 CFR 801 Subpart D) | 510(k) Number |

| | K070836 |
|--|----------------------------|
| | Over-The-Counter Use |
| | (Per 21 CFR 801 Subpart C) |

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

CleveX Inc. Proprietary and Confidential Information 1275 Kinnear Rd, Columbus, OH 43212 March 21, 2007