(64 days)
Not Found
Not Found
No
The summary describes a surgical drape made of fabric, with no mention of software, algorithms, or any technology related to AI or ML.
No
Explanation: Therapeutic devices directly treat or alleviate a medical condition. Surgical drapes are used to maintain a sterile field and prevent contamination, which is a supportive function during surgery, not a direct treatment of a disease or condition. They do not have a direct physiological or pharmacological effect.
No
The device is a surgical drape used to isolate a surgical incision site from contamination, not to diagnose a condition.
No
The device description clearly states it is comprised of a physical material (spunlaced nonwoven fabric) and is a protective patient covering, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the materials and construction of a surgical drape. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
Therefore, the Convertors® Surgical Drapes are a medical device, but they fall under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Convertors® Surgical Drapes are devices 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.
Product codes
KKX
Device Description
The drapes are comprised of a sing e layer of degradable spunlaced nonwoven fabric with various reinforcements. The fiber is water soluble in temperatures above approximate v 190 degrees F.
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 biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Isolyser Enviroguard Drapes.
Reference Device(s)
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
JAN 1 2 2000
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is slightly slanted to the right, giving it a dynamic appearance.
cGaw Park. Illinois 60085-6787 X- 847 785 2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Drapes
Manufacturer:
Allegiance Healthcare Corporation One Butterfield Trail El Paso, Texas 79906
- Regulatory Affairs Contact:
Sharon Robbins 1500 Waukegan Road MPWM McGaw Park, IL 60085 (847) 785-3311
Telephone:
September, 1999 Date Summary Prepared:
Common Name: Convertors® Surgical Drapes
Class II per 21CFR § 878.4370 Classification:
Predicate Device: Isolyser Enviroguard Drapes.
Description: The drapes are comprised of a sing e layer of degradable spunlaced nonwoven fabric with various reinforcements. The fiber is water soluble in temperatures above approximate v 190 degrees F.
Intended Use:
The Convertors® Surgical Drapes are devices 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.
1
Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a cluster of dots arranged in a cross-like shape. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Drapes
| Substantial Equivalence: | The Convertors® Surgical drapes are
substantially equivalent to the Isolyser
Enviroguard drapes in that: |
| -------------------------- | ---------------------------------------------------------------------------------------------------------------- |
|---|
- the intended use is the same
- the performance attributes are similar
- All materials used in the fabrication of this Summary of testing: Convertors® Surgical drapes were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Ms. Sharon Robbins Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re : K993795
Convertors® Surgical Drapes Trade Name: Requlatory Class: II Product Code: KKX Dated: November 8, 1999 November 9, 1999 Received:
Dear Ms. Robbins:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
3
Paqe 2 - Ms. Robbins
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.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 yours, Timotiny A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 347.473.1500 FAX: 847.785.2461
510(k) Number (if known):
Device Name:
Convertors® Surgical Drapes
Unknown
Indications For Use:
The Convertors® Surgical Drapes are devices 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) or
Over-The Counter Use
unter Use X
Qlin S. him
11
(Division Sign-Off) Division of Dental, Infection Con and General Hospi 510(k) Numbe
116