KAPP BARI-RING, MODEL KS-BR-2005

K050384 · Kapp Surgical Instrument, Inc. · NEU · Jan 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K050384
• Device Name: KAPP BARI-RING, MODEL KS-BR-2005
• Applicant: Kapp Surgical Instrument, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The KAPP Bari-Ring Endoscopic Marker is intended to radiographically (limited to xray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).

Device Story

Stainless steel ring; implanted during bariatric or other surgical procedures to mark gastropexy site; provides radiographic (x-ray) visibility for future diagnostic reference; used when stomach is inaccessible by standard contrast or endoscopy; deployed by surgeon; single-use; non-sterile supply; aids clinical decision-making by enabling post-operative visualization of surgical site.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel ring; implantable; radiographic (x-ray) marker; single-use; biocompatible materials.

Indications for Use

Indicated for patients undergoing bariatric or other surgical procedures requiring gastropexy, particularly when the stomach is inaccessible via standard contrast or endoscopic diagnostic methods.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Med-Edge Coronary Vein Graft Tag Marker (K971966)
• Voss Graft Marker (K895369)

Submission Summary (Full Text)

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K050384

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# Additional Requested Information, K050384

Section 510(k) Notification, Amended Submission KAPP Bari-Ring Model KS-BR-2005 Attachment 1A1 - 510(k) Summary

Kapp Surgical Instrument Co, Inc. 4919 Warrensville Center Rd. Cleveland, OH 44128

#### Summary Information:

JAN 1 3 2006

| Applicant: | Kapp Surgical Instrument Co., Inc.<br>4919 Warrensville Center Road<br>Cleveland, Ohio 44128<br>Tel: [phone]<br>Fax: [phone] | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact : | Albert Santilli, President | | |
| Prepared: | October 20, 2005 | | |
| Device Identification: | | | |

| Proprietary Name: | KAPP Bari-Ring Endoscopic Marker |
|-------------------------------------|-------------------------------------------------------|
| Common Name: | Implantable radiographic marker |
| Classification Name and Regulation: | Implantable clip, product code NEU<br>21 CFR 878.4300 |

Predicate Device(s): Med-Edge

## Device Description:

The KAPP Bari-Ring Endoscopic Marker consists of a stainless steel ring deployed during surgery supplied non-sterile for single long term use to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).

### Indications for use:

The KAPP Bari-Ring Endoscopic Marker is intended to be used to radiographically (limited to xray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy) .

# Comparison to the Predicate Devices:

The legally marketed predicate devices to which this device is substantially equivalent are: K971966, Med-Edge Coronary Vein Graft Tag Marker K895369, Voss Graft Marker

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# Additional Requested Information, K050384 Section 510(k) Notification, Amended Submission KAPP Bari-Ring Model KS-BR-2005

Kapp Surgical Instrument Co, Inc. 4919 Warrensville Center Rd. Cleveland, OH 44128

| | | | | Attachment 1A1 -- 510(k) Summary (continued) |
|--|--|--|--|----------------------------------------------|
|--|--|--|--|----------------------------------------------|

| Attribute | KAPP Bari-Ring<br>Endoscopic Marker | Med-Edge Coronary<br>Vein Graft Tag<br>Marker | Voss Graft Marker |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------|-------------------|
| Intended Use | | | |
| Intended to be used for<br>radiographically marking the<br>site of surgery during the<br>surgical procedure for future<br>surgical procedures. | YES | YES | YES |
| Single use device | YES | YES | YES |
| Design | | | |
| Same materials for invasive<br>contact well-known<br>biocompatible industry<br>standard | YES | YES | YES |
| Performance standards / Specifications | | | |
| Biocompatibility testing, and<br>bench testing support fact<br>that no new issues of safety,<br>effectiveness, or performance<br>raised | YES | YES | YES |

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Mr. Albert N. Santilli President KAPP Surgical Instrument Co., Inc. 4919 Warrensville Center Road CLEVELAND OH 44128

K050384 Re:

Trade/Device Name: KAPP Bari-Ring Endoscopic Marker Regulation Number: 21 CFR §878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: January 5, 2006 Received: January 6, 2006

Dear Mr. Santilli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave revewed your booking by equivalent (for the indications for use stated in above and have docemiinvarketed predicate devices marketed in interstate commerce prior to the cherosale) to regary maniental Device Amendments, or to devices that have been May 20, 1770, the chaoinent atte of wissions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordatios internet personal application (PMA). You may, therefore, market the do not require approval or a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general consisted 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 (Premarket If your device is classined (bot as a such additional controls. Existing major regulations affecting your Apploval), it thay be subject to eath-ederal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can of tound mouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please oc advisou mai 1 Dr i issues vour device complies with other requirements of the Act or any FDA has mast and regulations administered by other Federal agencies. You must comply with all the It caral statues and regulations as annothinited to registration and listing (21 CFR Part 807); labeling Act s requirements, modulity, but not annot as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter with anow you to begin maniems of your device of your device to a legally premarket notheation. The I DA miding of back.
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 If you desire specific advice for your device on our of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, " responsibilities under the Act from the 807.97). Tou may outlin outer general missistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Additional Requested Information, K050384 Section 510(k) Notification, Amended Submission KAPP Bari-Ring Model KS-BR-2005 АТТАСНМЕNT ЗА

Kapp Surgical Instrument Co, Inc. 4919 Warrensville Center Rd. Cleveland, OH 44128

#### Indications for Use

510(k) Number (if known):

Device Name: KAPP Bari-Ring Endoscopic Marker

Indications for Use:

The KAPP Bari-Ring Endoscopic Marker is intended to radiographically (Iimited to xray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy)

ア Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050384

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