(123 days)
proMedical Products Co. LTD intends to market Non-sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination
Non-sterile Disposable Surgical Drapes made of natural or synthetic material.
The provided text is related to a 510(k) premarket notification for "Non-sterile Disposable Surgical Drapes." This document focuses on the regulatory clearance for a medical device (surgical drapes), and as such, it does not contain information about product performance acceptance criteria or a study proving its performance in the way a diagnostic or AI-driven device would.
The 510(k) process for devices like surgical drapes primarily involves demonstrating "substantial equivalence" to a predicate device. This is achieved through comparisons of material, manufacturing processes, intended use, and conformance to relevant industry standards (e.g., for sterility, barrier properties, tensile strength, etc.), rather than clinical performance metrics like accuracy, sensitivity, or specificity.
Therefore, most of the requested information (items 1-9) cannot be extracted from this document because it describes a different type of regulatory submission and product.
Here's a breakdown of what can be extracted or inferred, and why the other points are not applicable:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not present in this document. For surgical drapes, acceptance criteria would typically relate to physical properties (e.g., fluid resistance, tensile strength, linting, flammability, cytotoxicity) and manufacturing standards (e.g., sterility assurance level if sterile, biocompatibility). These specifics are not detailed in this high-level regulatory summary. The document states "substantial equivalence" to predicate devices, implying it meets similar performance standards, but doesn't list them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not present. Clinical performance studies with test sets are not typically required or described for 510(k) submissions of devices like surgical drapes. The "testing" would involve laboratory-based characterization of materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not present. Ground truth establishment by experts is relevant for diagnostic devices interpreting complex data (like medical images). It does not apply to surgical drapes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present. Adjudication relates to resolving discrepancies in expert interpretations, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not present. MRMC studies are for evaluating diagnostic accuracy, especially with AI assistance. This device is a surgical drape, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not present. This applies to AI algorithms, not physical medical devices like drapes.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not present. Ground truth is not a concept applied in the same way for these types of devices. Compliance with industry standards and material specifications would be the "truth" here.
8. The sample size for the training set
- Not applicable / Not present. Training sets are used for machine learning models. This is a physical product.
9. How the ground truth for the training set was established
- Not applicable / Not present. See point 8.
Summary regarding the provided document:
This 510(k) notification focuses on establishing "substantial equivalence" of "proMedical Surgical Drapes" to already legally marketed predicate devices (Primeline (Primaguard) surgical drapes (K021864) and Medline (Proxima) surgical drapes (K964142)). The FDA determined this equivalence, allowing the device to be marketed. The information typically found in such a submission (but not fully detailed in this letter) would include:
- Intended Use: "Non-sterile surgical drapes ... intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination."
- Classification: Class II, product code KKX, regulation number 878.4370.
- Comparison to Predicates: The 510(k) submission would have contained detailed comparisons of the device's material properties, design, manufacturing processes, and performance characteristics (e.g., barrier properties, fluid resistance, strength) to the predicate devices, likely citing adherence to recognized consensus standards. However, these specific details are not present in the provided excerpts.
In conclusion, the provided text does not describe acceptance criteria and a study proving device performance in the context of diagnostic accuracy or AI performance, as it pertains to a different class and type of medical device undergoing a different regulatory pathway.
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| DEC 1 0 2004 | 510(k) Notification |
|---|---|
| -------------- | --------------------- |
SECTION A – GENERAL INFORMATION
| Date: | August 3, 2004 |
|---|---|
| Applicant's Name: | proMedical Products Co. LTD |
| Address: | #206 Huang He Road WestChangzhou New DistrictChangzhou, JiangsuChina 213022 |
| Phone:Fax: | 011-86-0519-5115027011-86-519-5115027 |
| Contact Name/U.S Authorized Rep: | Mr. David Power5165 Broadway #116Depew, NY 14043-4012 |
| Phone:Fax: | 716-655-3432716-655-3432 |
| Manufacturing Location: | proMedical Products Co. LTD#206 Huang He Road WestChangzhou New DistrictChangzhou, JiangsuChina 213022 |
| Owner/Operator No. | 9064470 |
| Establishment Registration No. | N/A - awaiting assignment of number |
| Common Name of Device: | Non-sterile Disposable Surgical Drapes |
| Trade Name: | proMedical Surgical Drapes |
| Classification: | Class II |
| Product Code: | KKX |
| Regulation Number: | 878.4370 |
| Purpose of Submission: | New Device |
Page I-I
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KC42.3i
Predicate Device(s):
510k Prepared by:
Primeline (Primaguard) surgical drapes (K021864) Medline (Proxima) surgical drapes (K964142)
Boyd Harris 125 Clements Ave Starkville, MS 39759 662-312-0898 (Phone) 662-324-6347 (Fax) kotacan@hotmail.com (email)
- Please refer all questions, request for additional information, and/or any correspondence regarding this 510(k) submission to Boyd Harris using the above contact information.
Applicant's Signature:
David Power
Mr. David Power
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 eagle emblem with three curved lines representing the bird's wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. Boyd Harris Director, Quality Assurance/Regulatory Affairs proMedical Products Company, Limited 125 Clements Avenue Starkville, Mississippi 39759
Re: K042131
Trade/Device Name: Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: October 15, 2004 Received: October 18, 2004
Dear Mr. Harris:
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 (1 wr 1, vice 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.
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Page 2 - Mr. Harris
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 Office of Compliance at (240) 276-0115. 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,
Susan Rumm
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510k Number (if known): K042131
Surgical Drapes Device Name:
Indications For Use:
proMedical Products Co. LTD intends to market Non-sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutte Michau Cms.
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control. Dental Devices
510(k) Number. K04213/
Page 1 of
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.