(47 days)
Not Found
Not Found
No
The summary describes a mechanical device (scalp clip) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as stopping bleeding during surgery, which is a surgical tool function, not typically a therapeutic device that treats a condition or disease.
No
Explanation: The device description states its purpose is to "stop bleeding during surgery on the scalp," which is a treatment function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device is described as a "STORZ Raney Scalp Clip," which is a physical device used to stop bleeding. There is no mention of software in the provided summary.
Based on the provided information, the STORZ Raney Scalp Clip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stop bleeding during surgery on the scalp." This is a direct surgical intervention on a living patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is a surgical tool used to physically control bleeding during a procedure.
N/A
Intended Use / Indications for Use
The STORZ Raney Scalp Clip is a device designed to stop bleeding during surgery on the scalp.
Product codes
HBO
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4150 Scalp clip.
(a)
Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
Rudolf Storz GmbH c/o Ms. Angelika Scherp Business Support International Amstel 320-1 Amsterdam, Netherlands 1017AP
Re: K033660
Trade/Device Name: Scalp Clips Regulation Number: 21 CFR 882.4150 Regulation Name: Scalp clip Regulatory Class: II Product Code: HBO Dated: November 21, 2003 Received: November 24, 2003
Dear Ms. Scherp:
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 (o devices that have been rcclassified 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 mistranding and adultcration.
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 he 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.
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 sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Angelika Scherp
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K033660 |
|---|---|
| Device Name: | Scalp Clips |
| Indications For Use: | The STORZ Raney Scalp Clip is a device designed to stop |
| bleeding during surgery on the scalp. |
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR .
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
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KO33660 510(k) Number_