(123 days)
Not Found
No
The summary describes a simple, non-sterile surgical drape made of natural or synthetic material, with no mention of AI, ML, image processing, or any other computational technology.
No
The device is a surgical drape, which is a protective covering used to isolate a surgical site from contamination, not to treat a disease or condition.
No
The intended use of the device is to be a protective patient covering during surgery to isolate the surgical site from contamination, which is not a diagnostic function.
No
The device description explicitly states it is made of "natural or synthetic material," indicating a physical product, 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 clearly stated as a "protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during surgery.
- Device Description: The device is described as "Non-sterile Disposable Surgical Drapes made of natural or synthetic material." This aligns with the intended use as a physical barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
- Predicate Devices: The predicate devices listed are also surgical drapes, which are not IVDs.
Therefore, the description and intended use clearly indicate that this device is a surgical drape, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
KKX
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
| 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 West |
| Changzhou New District | |
| Changzhou, Jiangsu | |
| China 213022 | |
| Phone: | |
| Fax: | 011-86-0519-5115027 |
| 011-86-519-5115027 | |
| Contact Name/U.S Authorized Rep: | Mr. David Power |
| 5165 Broadway #116 | |
| Depew, NY 14043-4012 | |
| Phone: | |
| Fax: | 716-655-3432 |
| 716-655-3432 | |
| Manufacturing Location: | proMedical Products Co. LTD |
| #206 Huang He Road West | |
| Changzhou New District | |
| Changzhou, Jiangsu | |
| China 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
1
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
2
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.
3
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
4
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)