(332 days)
Not Found
No
The device is a passive marker and the summary does not mention any software or analytical capabilities, let alone AI/ML.
No
The device is described as an endoscopic marker used to mark a surgical site for radiographic purposes, not to treat a disease or condition.
No
The device is an endoscopic marker used to physically mark a surgical site for future radiographic identification, not to diagnose a condition itself. It aids in locating a site that might otherwise be inaccessible by diagnostic means but doesn't perform a diagnostic function.
No
The device description explicitly states it consists of a "stainless steel ring deployed during surgery," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- KAPP Bari-Ring Function: The KAPP Bari-Ring is a physical marker implanted inside the body during surgery. Its purpose is to be visible on X-rays to indicate a specific surgical site. It does not analyze or test any biological specimens.
The description clearly states it's a physical ring deployed during surgery to radiographically mark a site. This is an in-vivo (within the body) device, not an in-vitro (outside the body) diagnostic.
N/A
Intended Use / 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).
Product codes
NEU
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
stomach
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing, and bench testing support fact that no new issues of safety, effectiveness, or performance raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
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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.
4919 Warrensville Center Road
Cleveland, Ohio 44128
Tel: (216) 587-4400
Fax: (216) 587-0411 | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 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 |
| 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
1
Z of Z
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
Endoscopic Marker | Med-Edge Coronary
Vein Graft Tag
Marker | Voss Graft Marker |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------|-------------------|
| Intended Use | | | |
| Intended to be used for
radiographically marking the
site of surgery during the
surgical procedure for future
surgical procedures. | YES | YES | YES |
| Single use device | YES | YES | YES |
| Design | | | |
| Same materials for invasive
contact well-known
biocompatible industry
standard | YES | YES | YES |
| Performance standards / Specifications | | | |
| Biocompatibility testing, and
bench testing support fact
that no new issues of safety,
effectiveness, or performance
raised | YES | YES | YES |
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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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