(92 days)
The KAPP Bari-Ring Endoscopic Marker is intended to be used 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 KAPP Bari-Ring Endoscopic Marker consists of a nickel titanium stainless steel ring deployed during surgery. It is supplied non-sterile for single long term (30 day) use to mark the spot expected to require further surgery within 30 days. The ring is homogenously constructed of a ring of nickel titanium conforming to ASTM F 2063-05.
The provided text describes a 510(k) summary for the KAPP Bari-Ring Endoscopic Marker, focusing on its substantial equivalence to previously marketed devices. This type of submission relies on demonstrating that a new device is as safe and effective as a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies for an AI/ML device is not applicable in this context.
Here's an breakdown of the available information and why other items are not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The submission does not specify numerical acceptance criteria for clinical performance for the new KAPP Bari-Ring Endoscopic Marker. Instead, the approach is to demonstrate substantial equivalence to predicate devices in specified areas.
- Reported Device Performance:
Performance Area Result / Conclusion Corrosion resistance Tests demonstrated substantial equivalence. Hardness Tests demonstrated substantial equivalence. Tensile Tests demonstrated substantial equivalence. Overall Conclusion The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission details the premarket notification for a physical medical device (an endoscopic marker), not an AI/ML diagnostic or predictive tool. Therefore, there is no "test set" in the context of AI/ML performance evaluation (e.g., images for classification). The "tests" mentioned are laboratory tests on the material properties of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, there is no "test set" requiring ground truth established by experts for an AI/ML algorithm.
4. Adjudication method for the test set
- Not Applicable. No test set in the AI/ML context.
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 is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not Applicable. Ground truth in the context of AI/ML performance is not relevant here. The evaluation of this device is based on laboratory test results (corrosion resistance, hardness, tensile strength) to demonstrate that its physical properties are comparable to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set.
In summary: The provided 510(k) summary is for a physical medical device (KAPP Bari-Ring Endoscopic Marker) and focuses on demonstrating substantial equivalence to predicate devices through physical and material property testing, rather than performance of an AI/ML algorithm against specific acceptance criteria. Therefore, the questions related to AI/ML study design and metrics are not applicable to this document.
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510(k) Summary
| Submitter: | Kapp Surgical Instrument, Inc4919 Warrensville Center RoadCleveland, OH 44128FDA |
|---|---|
| Contact person: | Albert SantilliPresidentKapp Surgical Instrument, Inc4919 Warrensville Center RoadCleveland, OH 44128Phone: (216) 587-4400Fax: (216) 587-0411E-mail: ans@kappsurgical.com |
| Date summary prepared: | August 8, 2007 |
| Device trade name: | Bari-Ring Endoscopic Marker |
| Device common name: | Marker Ring |
| Device classificationname: | Marker, Radiographic, ImplantibleNEU21 CFR Part 878.4300 |
| Legally marketeddevices to which thedevice is substantiallyequivalent: | KAPP Bari-Ring Endoscopic Marker, Model KS-BR-2005, K050384MRI Devices Corporation ClipLoc Soft Tissue Marker, K033447 |
| Description of thedevice: | The KAPP Bari-Ring Endoscopic Marker consists of a nickeltitanium stainless steel ring deployed during surgery. It is suppliednon-sterile for single long term (30 day) use to mark the spotexpected to require further surgery within 30 days.The ring is homogenously constructed of a ring of nickel titaniumconforming to ASTM F 2063-05. |
| Intended use of thedevice: | The KAPP Bari-Ring Endoscopic Marker is intended to be used forradiographically marking the current site of surgery for futuresurgical procedures. |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate device(s). |
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Performance tests:
Tests were performed to demonstrate substantial equivalence in the following areas:
- Corrosion resistance .
- Hardness .
- Tensile .
Conclusions:
The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three horizontal bars that are angled upwards and to the right, resembling a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Albert N. Santilli, Ph.D. President Kapp Surgical Instrument, Inc. 4919 Warrrensville Center Rd. CLEVELAND OH 44128
Re: K072216
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: October 9, 2007 Received: October 11, 2007
Dear Dr. Santilli:
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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 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
Page 2
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INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K072216 |
|---|---|
| Device Name: | KAPP Bari-Ring Endoscopic Marker |
| Indications for Use: | The KAPP Bari-Ring Endoscopic Marker is intended to be used 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). |
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)
Helen Preusser
(Division Sign Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number
§ 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.