(90 days)
Not Found
No
The 510(k) summary describes surgical patties used for fluid absorption and hemostasis during neurosurgical procedures. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The predicate device is also a surgical patty, further indicating a traditional medical device without AI/ML components.
No
The device is described as a surgical accessory used to protect tissue, absorb fluids, and stop bleeding during neurosurgical procedures, rather than to treat a specific disease or condition.
No
The intended use describes the device's function as protecting tissue, absorbing fluids, and stopping bleeding during neurosurgical procedures. This points to a therapeutic or supportive role during surgery, not a diagnostic one.
No
The device is described as "patties" used in neurosurgical procedures, which are physical objects (likely sponges or similar materials) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for neurosurgical procedures to protect tissue, absorb fluids, and stop bleeding. This is a direct surgical intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device is used directly on the surgical site.
Therefore, the device described falls under the category of a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.
Product codes
HBA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).
0
K 014268
MAR 2 7 2002
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | PMI
8211 Compton Way
Melbourne, FL 32940
Phone: 321-751-4307
Fax: 321-751-4307 |
|------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | |
| Date of Summary: | December 2, 2001 |
| Classification Name: | Tape and bandage, Adhesive |
| Device Name: | Paddie, Cottonoid |
| Proprietary Name: | Norapad |
| Regulatory Class: | II |
| Classification Number: | HBA |
| Predicate Device: | |
| K993019 | Pacific Surgical Patties
Pacific Surgical Innovations, Inc |
Intended Use:
Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Perlei Medical, Inc. c/o Mr. Arthur J. Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, Florida 33572
Re: K014268
Trade Name: Norapad Plain Regulation Number: 882.4700 Regulation Name: Cottonoid paddie Regulatory Class: II Product Code: HBA Dated: December 2, 2001 Received: December 27, 2001
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
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.
2
Page 2 - Mr. Arthur Ward
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, «Misbranding by reference to premarket notification» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Muiam C. Provost
for 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
3
510(k) Number (if known):
Device Name: PMI Norapad
Indications For Use:
Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a Variety of sizes necessary to meet clinical needs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER 'AGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
4.4
OR
Over-The-Counter Use (Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_Ko14268