(91 days)
Not Found
Not Found
No
The document describes a sterile equipment drape made of polyurethane film and provides performance data related to viral penetration and flammability. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device is described as equipment drapes used to cover surgical and non-surgical equipment, which serves a protective or barrier function, not a therapeutic one.
No
The device is described as an equipment drape used to cover surgical and non-surgical equipment, and its performance studies focus on material properties like viral penetration and flammability, not on diagnosing medical conditions.
No
The device description clearly states it consists of "polyurethane film that is cut and configured to specification," indicating a physical, hardware-based product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cover a variety of surgical and non-surgical equipment in various clinical settings." This describes a physical barrier or covering for equipment, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is described as "polyurethane film that is cut and configured to specification." This is a material used for drapes, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or prediction of disease
- Reagents, calibrators, or controls
The device is clearly intended for use as a physical drape in a clinical setting, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
Advance Medical Designs Slush Drapes are equipment covers used to cover a variety of surgical and non surgical equipment in various clinical settings. It is to be used in General and Endoscopic surgery for use with Saline.
Product codes
KKX
Device Description
The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
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)
The material used in this product has been tested to ASTM Mcthod F 1671 for Viral Penetration and to 16 CFR Part 1610 for Flammability.
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.
MicroTek Equipment Drapes
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
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
ATTACHMENT 2
16 ...
Substantial Equivalence 510(k) Summary
Advance Medical Designs, Inc Equipment Slush Drape
To Whom It May Concern:
Date: 02/27/2006
Submitter/ Contact Name and Address William Slevin Advance Medical Designs, Inc. 1241 Atlanta Industrial Drive Marietta, GA 30066
Tel: (770) 422-3125
Trade Name: Advance Medical Designs, Inc Equipment Slush Drape
Classification Name: Drape, Surgical
Common/ Usual Name: Equipment Slush Drape
Predicate Legally Marketed Device: MicroTek Equipment Drapes
Intended Use:
Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
Description of the Device:
The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
1
:
Performance
The material used in this product has been tested to ASTM Mcthod F 1671 for Viral Penetration and to 16 CFR Part 1610 for Flammability.
2
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The symbol in the center consists of three curved lines that appear to be stylized representations of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 16 2008
Mr. William Slevin Ouality Assurance Regulatory Affairs Advance Medical Designs, Incorporated 1241 Atlanta Industrial Drive Marietta, Georgia 30066
Re: K053495
Trade/Device Name: Equipment Slush Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 10, 2006 Received: March 13, 2006
Dear Mr. Slevin:
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 Eederal Register.
3
Page 2 -- Mr. Slevin
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/industry/support/index.html.
Sincerely yours,
Cluts
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
4
Indications for Use
510(k) Number (if known): 长 053495
Device Name: Slush Drape
Indications For Use:
Advance Medical Designs Slush Drapes are equipment covers used to cover a variety of surgical and non surgical equipment in various clinical settings. It is to be used in General and Endoscopic surgery for use with Saline.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) | Page 1 of 1 |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K053495 |
... ... ..