(92 days)
Not Found
No
The device description and performance studies focus on the physical properties and equivalence to predicate devices, with no mention of AI or ML for image analysis or other functions.
No
This device is an endoscopic marker used to mark a surgical site for radiographic visibility, not to treat a disease or condition.
No
The device is described as an "Endoscopic Marker" intended to "mark the site of gastropexy" for radiographic visibility. Its purpose is to physically mark a location, not to diagnose a condition or disease. It facilitates a diagnostic method (x-ray) but is not diagnostic itself.
No
The device description explicitly states it consists of a physical ring made of nickel titanium stainless steel, which is a 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 for diagnosis, monitoring, or screening.
- Device Function: The KAPP Bari-Ring Endoscopic Marker is a physical marker implanted during surgery to be visualized by X-ray. It does not analyze any biological specimens.
- Intended Use: Its intended use is to radiographically mark a surgical site, not to diagnose a condition based on analysis of bodily fluids or tissues.
Therefore, based on the provided information, the KAPP Bari-Ring Endoscopic Marker falls under the category of a surgical implant or marker, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KAPP Bari-Ring Endoscopic Marker is intended to be used for radiographically marking the current site of surgery for future surgical procedures.
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).
Product codes
NEU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
site of gastropexy / 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)
Tests were performed to demonstrate substantial equivalence in the following areas:
- Corrosion resistance .
- Hardness .
- Tensile .
The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
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
.
510(k) Summary
| Submitter: | Kapp Surgical Instrument, Inc
4919 Warrensville Center Road
Cleveland, OH 44128FDA |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Albert Santilli
President
Kapp Surgical Instrument, Inc
4919 Warrensville Center Road
Cleveland, OH 44128
Phone: (216) 587-4400
Fax: (216) 587-0411
E-mail: ans@kappsurgical.com |
| Date summary prepared: | August 8, 2007 |
| Device trade name: | Bari-Ring Endoscopic Marker |
| Device common name: | Marker Ring |
| Device classification
name: | Marker, Radiographic, Implantible
NEU
21 CFR Part 878.4300 |
| Legally marketed
devices to which the
device is substantially
equivalent: | KAPP Bari-Ring Endoscopic Marker, Model KS-BR-2005, K050384
MRI Devices Corporation ClipLoc Soft Tissue Marker, K033447 |
| Description of the
device: | 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. |
| Intended use of the
device: | The KAPP Bari-Ring Endoscopic Marker is intended to be used for
radiographically marking the current site of surgery for future
surgical procedures. |
| Technological
characteristics: | The proposed device has the same technological characteristics as
the 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.
2
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.
3
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
4
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