(204 days)
Not Found
Not Found
No
The device description and performance summary describe a simple cotton pad with fluid absorption properties, with no mention of AI or ML.
No.
The device's intended uses (protecting tissue, absorbing fluids, stopping bleeding) are supportive functions during surgery, not direct therapeutic interventions to treat or cure a disease or condition. It is a surgical accessory.
No
The device, a cotton pad for fluid absorption and hemostasis during surgery, does not provide any diagnostic information or analysis. Its function is entirely therapeutic/supportive.
No
The device description clearly states it is a "cotton pad," which is a physical hardware component, 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 "To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding." This describes a device used during a surgical procedure on a patient's body, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description is "A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding." This further reinforces its use as a surgical tool, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue samples, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device described is a surgical accessory used for physical functions (protection, absorption, hemostasis) during an operation.
N/A
Intended Use / Indications for Use
The Pacific Surgical Patties are intended for use in 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.
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Product codes
HBA
Device Description
A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding.
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
Pacific Surgical Patties provide X-ray detectable sterile patties that absorb fluids at 6.5 times its dry weight and functions in the same manner as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Codman Surgical Patties
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
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Page 8
SECTION 6
510(k) STATEMENT
| Submitter Name: | Pacific Surgical Innovations, Inc. |
|---|---|
| Submitter's Address: | 360 Industrial Road, Unit H |
| San Carlos, CA 94070 | |
| Contact Person: | Terry Johnston, President |
| Phone Number: | 650-802-6988 |
| Facsimile Number: | 650-802-0120 |
| Date Prepared: | August 26, 1999 |
| Device Trade Name: | Pacific Surgical Patties |
| Device Common Name: | Cottonoid Pattie |
| Classification Name: | Cottonoid Paddie |
| Predicate Device: | Codman Surgical Patties |
| Device Description: | A cotton pad used during surgery to protect |
| nervous tissue, absorb fluids or stop bleeding. | |
| Intended Use: | The Pacific Surgical Patties are intended for use |
| in 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. | |
| Technological Characteristics | |
| and Comparison to Predicate: | The Pacific Surgical Patties are manufactured from |
| equivalent materials meeting the same or similar | |
| standards, dimensional specifications and quality | |
| conditions as the predicate device. | |
| Performance Data: | Pacific Surgical Patties provide X-ray detectable |
| sterile patties that absorb fluids at 6.5 times its dry | |
| weight and functions in the same manner as the | |
| predicate. |
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Conclusion:
The Pacific Surgical Patties are as safe and effective for its intended use, and meets all regulatory requirements to be found substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the bottom line.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
MAR 3 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry Johnston President Pacific Surgical Innovations, Inc. 360 Industrial Road, Unit H San Carlos. California 94070
K993019 Re: Trade Name: Surgical Patties Regulatory Class: II Product Code: HBA Dated: March 13, 2000 Received: March 13, 2000
Dear Mr. Johnston:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Terry Johnston
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours,
Nil RP Ogden
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K993019
Page 7
SECTION 5
INDICATIONS FOR USE
Device Name:
Pacific Surgical Patties
Indications for Use:
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Nro for cmw
(9930
Prescription Use
OR Over the Counter _____________________________________________________________________________________________________________________________________________________________