(204 days)
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.
A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding.
This document describes the marketing authorization for the Pacific Surgical Patties, a surgical cotton pad. The authorization is based on a finding of substantial equivalence to a predicate device, the Codman Surgical Patties.
Here's an analysis of the acceptance criteria and the study presented:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance |
|---|---|
| Equivalent materials to predicate device | Manufactured from equivalent materials meeting the same or similar standards. |
| Similar standards to predicate device | Manufactured from materials meeting the same or similar standards. |
| Dimensional specifications similar to predicate device | Meets similar dimensional specifications. |
| Quality conditions similar to predicate device | Meets similar quality conditions. |
| X-ray detectable | X-ray detectable. |
| Sterile | Sterile patties. |
| Absorb fluids | Absorbs fluids at 6.5 times its dry weight. |
| Functions in the same manner as the predicate | Functions in the same manner as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not explicitly describe a "test set" in the context of an algorithmic or AI-based device. The approval is for a physical medical device (surgical patties). The performance data cited appears to be based on an internal assessment or comparison of the Pacific Surgical Patties to the predicate device, focusing on material and functional equivalence. There is no mention of a traditional "test set" as would be used for evaluating the performance of a diagnostic or predictive algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set in the context of diagnostic performance. The evaluation is based on the physical and functional characteristics of the surgical patties compared to a predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no described test set requiring adjudication in the context of diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This type of study is not relevant to the described medical device (surgical patties). MRMC studies are typically used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No. This is not an AI-based device, so standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used for this device is the performance and characteristics of the legally marketed predicate device (Codman Surgical Patties). The key argument for acceptance is that the Pacific Surgical Patties are "as safe and effective" and "meets all regulatory requirements to be found substantially equivalent" to this predicate. The performance data focuses on demonstrating this equivalence through properties like material composition, dimensional specifications, quality, sterility, X-ray detectability, and fluid absorption capacity.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device that requires a training set.
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SECTION 6
510(k) STATEMENT
| Submitter Name: | Pacific Surgical Innovations, Inc. |
|---|---|
| Submitter's Address: | 360 Industrial Road, Unit HSan 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 protectnervous tissue, absorb fluids or stop bleeding. |
| Intended Use: | The Pacific Surgical Patties are intended for usein neurosurgical procedures to protect tissue, absorbfluids and stop bleeding. They are supplied to theuser in sterile packages. These patties are X-raydetectable and are provided in a variety of sizesnecessary to meet clinical needs. |
| Technological Characteristicsand Comparison to Predicate: | The Pacific Surgical Patties are manufactured fromequivalent materials meeting the same or similarstandards, dimensional specifications and qualityconditions as the predicate device. |
| Performance Data: | Pacific Surgical Patties provide X-ray detectablesterile patties that absorb fluids at 6.5 times its dryweight and functions in the same manner as thepredicate. |
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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.
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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.
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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
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K993019
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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 _____________________________________________________________________________________________________________________________________________________________
§ 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).