(332 days)
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).
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).
The provided text pertains to a 510(k) premarket notification for the KAPP Bari-Ring Endoscopic Marker. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving device efficacy through extensive clinical studies with specified acceptance criteria and measured performance in the way a Class III device or new technology would. Therefore, the information requested in the prompt, particularly points 2-7, which relate to detailed study design and statistical performance, is largely not applicable or present in this document.
The document primarily focuses on comparing the new device's intended use, design, and performance standards/specifications to those of legally marketed predicate devices to establish substantial equivalence.
Here's an attempt to address the prompt based on the available information:
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) for a substantially equivalent device, the "acceptance criteria" are not reported as specific performance metrics against a threshold. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as the predicate device(s). The "performance" is described in terms of shared attributes and testing.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (KAPP Bari-Ring) |
|---|---|
| Intended Use Equivalence: | |
| Intended to be used for radiographically marking the site of surgery during the surgical procedure for future surgical procedures. | YES - Intended to radiographically mark the site of gastropexy performed during bariatric or other surgical procedures. |
| Single use device. | YES |
| Design Equivalence: | |
| Same materials for invasive contact, well-known biocompatible industry standard. | YES - Consists of a stainless steel ring. (Stainless steel is a well-known biocompatible material for implants). |
| Performance Standards / Specifications Equivalence: | |
| Biocompatibility testing, and bench testing support the fact that no new issues of safety, effectiveness, or performance are raised. | YES - Biocompatibility testing and bench testing were performed to support equivalence. |
Note: The document states "Biocompatibility testing, and bench testing support fact that no new issues of safety, effectiveness, or performance raised" which is the reported "performance" in the context of a 510(k) submission, confirming it meets the regulatory expectation for equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical study with a "test set" in the context of device performance metrics. The demonstration of equivalence primarily relies on material properties, design, and intended use comparison, along with general biocompatibility and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. No specific "ground truth" establishment by external experts for a test set is described. The relevant "experts" would be the engineers and scientists at Kapp Surgical Instrument Co. responsible for design, testing, and regulatory submission, and the FDA reviewers themselves.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method for a test set is described as there isn't a performance study with a test set in the clinical sense.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an implantable radiographic marker, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implantable radiographic marker, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. For the purpose of a 510(k), the "ground truth" is that the predicate devices are legally marketed and have demonstrated safety and effectiveness for their intended use. The new device's "ground truth" is its physical and material properties (e.g., biocompatibility) meet recognized standards, which are evaluated through bench testing. No clinical "ground truth" derived from patient outcomes or pathology is detailed in this document.
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not an AI/machine learning device. The "training" for such a device would be based on established engineering principles, material science, and regulatory standards.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this question is not applicable.
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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 RoadCleveland, Ohio 44128Tel: (216) 587-4400Fax: (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 NEU21 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-RingEndoscopic Marker | Med-Edge CoronaryVein Graft TagMarker | Voss Graft Marker |
|---|---|---|---|
| Intended Use | |||
| Intended to be used forradiographically marking thesite of surgery during thesurgical procedure for futuresurgical procedures. | YES | YES | YES |
| Single use device | YES | YES | YES |
| Design | |||
| Same materials for invasivecontact well-knownbiocompatible industrystandard | YES | YES | YES |
| Performance standards / Specifications | |||
| Biocompatibility testing, andbench testing support factthat no new issues of safety,effectiveness, or performanceraised | 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 (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
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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
Page | of /
§ 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.