(176 days)
Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.
Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.
Guangzhou Fortunique Drapes, Bags and Covers are made of low density polyethylene film ir various sizes and shapes for use in covering equipment. These drapes, bags and covers are offered non-sterile in bulk quantities and sterile in individual packs.
This submission, K041501, is for Guangzhou Fortunique Drapes, Bags and Covers. This is a 510(k) summary for a Class II medical device, and as such, it does not typically involve the types of studies (like MRMC or standalone performance studies with ground truth established by experts) that are common for AI/ML-driven devices or diagnostic tools. Its clearance is based on substantial equivalence to predicate devices, which focuses on comparing physical characteristics and intended use rather than quantitative performance metrics against a defined acceptance criterion.
Therefore, many of the requested categories are not applicable to this type of device submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device Comparison) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Same intended use as predicate devices | "have the same intended use" |
| Manufactured of same polyethylene film | "are manufactured of the same polyethylene film" |
| Offered in same sizes and configurations | "they are offered in the same sizes and configurations" |
| Same physical characteristics | "they have the same physical characteristics" |
2. Sample size used for the test set and the data provenance
Not applicable. Substantial equivalence for this type of device is based on a direct comparison of features and intended use to existing predicate devices, not on a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment by experts is not relevant for this type of device comparison.
4. Adjudication method for the test set
Not applicable. There was no test set or adjudication method described.
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. This is not an AI/ML-driven device or a diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not applicable. The basis for clearance is substantial equivalence to predicate devices, not a ground truth against which a device's diagnostic performance is measured. The "ground truth" implicitly used is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Page 48
| Attachment 4: | 510 (k) Summary | |
|---|---|---|
| NOV 3 0 2004 | ||
| 510(k) Summary | ||
| Manufacturer: | Guangzhou Fortunique Ltd.Block B2 Zhou Shan GangShi Bei Ind. Ave. Pan Yu DistrictGuangzhou511410, China | |
| Contact: | Jane B. Campbell | |
| Address: | J. & D. Campbell Associates, Inc.485 LaRoe RoadChester, New York 10918 | |
| Telephone: | (845)469-4289 | |
| Fax: | 845-469-4212 | |
| Email: | jdca@optonline.net | |
| Date Summary Prepared: | May 27, 2004 | |
| Product Trade Name: | Guangzhou Fortunique Drapes, Bags and Covers | |
| Common Name: | Equipment drapes, bags and covers | |
| Classification: | II | |
| Predicate Devices: | Medline Band Bags and Equipment Covers K032065primaGARD Surgical Equipment Covers K022868Coverall All Equipment Covers Banded Bags & DomeBags, Various Models, Sterile and Non-sterile K023540International MedSurge Connections Equipment Covers -K014239United States Surgical Corporation Equipment CoversK961699Pinnacle Products Coverall All, Chair Sleeve, Drape-it-All,Tray Sleeve and related products K962288 | |
| Description: | Guangzhou Fortunique Drapes, Bags and Covers are made oflow density polyethylene film ir various sizes and shapes foruse in covering equipment. These drapes, bags and covers areoffered non-sterile in bulk quantities and sterile in individualpacks. | |
| Intended Use: | Guangzhou Fortunique's Drapes, Bags and Covers are intendedto cover equipment, to maintain a sterile field and as an aid inthe clean up of equipment after surgery or other medicalprocedures. These drapes, bags and covers are not intended tobe used as patient drapes and they have no patient contact. | |
| Fortunique intends to manufacture and market Drapes, Bagsand Covers sterile in ready to use form and will also providethem in non-sterile form to other companies for inclusion inconvenience packages which they will then sterilize. | ||
| Substantial Equivalence: | The Fortunique Drapes, Bags and Covers are substantiallyequivalent to the predicate devices listed above in that they- have the same intended use- are manufactured of the same polyethylene film- they are offered in the same sizes and configurations- they have the same physical characteristics |
June 4, 2004
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2004
Guangzhou Fortunique, Limited C/O Ms. Jane B. Campbell US Agent/Official Correspondent J. & D. Campbell Associates, Incorporated 485 LaRoe Road Chester, New York 10918
Re: K041501
Trade/Device Name: Guangzhou Fortunique Drapes, Bags and Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX, MMP Dated: October 7, 2004 Received: October 8, 2004
Dear Ms. Campbell:
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 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.
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Page 2 - Ms. Campbell
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.
Susabunner
Sue Chin-Lin, Ph.D.
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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June 4, 2004
Indications for Use Statement
510(k): 04150
Device Name: Guangzhou Fortunique Drapes, Bags and Covers
Intended Use: Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.
Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.
Susan Runn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number: KA1506
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C) ✓
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.