(104 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties of an absorbent drape, with no mention of AI or ML.
No
The device is described as an absorbent drape used to absorb fluids during surgical procedures, which is a supportive function rather than a therapeutic one that treats or prevents disease.
No
The device description states it is "used to absorb fluids during surgical procedures," which is a functional role for fluid management, not for diagnosing conditions.
No
The device description clearly states it is a physical drape made of layered absorbent material, 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 to "absorb fluids during surgical procedures." This is a physical function performed on the patient's body or in the surgical field, not an in vitro test performed on a sample taken from the body.
- Device Description: The description details a physical drape with absorbent and non-permeable layers. It doesn't mention any reagents, test strips, or components used to analyze biological samples.
- Performance Studies: The performance studies focus on physical properties like absorbency and strength, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.
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 Mentor Absorbent Drape was tested for absorbency and found to absorb at least 100 cc per ft2 of saline solution without leaking. The absorbent material did not leak out of the pad.
The Mentor Absorbent Drape was tested for strength under simulated clinical use conditions and was found to not rip, tear or separate during the testing.
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.
Not Found
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
K97314//p
DEC - 4 1997
510(k) SUMMARY MENTOR ABSORBENT DRAPE
This 510(k) summary of safety and effectiveness information is being submitted
This 510(k) summary of safety and effectiveness information is being and summary of surely and equirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K973146
Submitter/ Donna A. Crawford Contact Person: Manager, Corpporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111
(805) 681-6000 Telephone: (805) 681-6004 FAX:
October 28, 1997 Date Prepared:
Device Name and Classification
Proprietary Name: Common/Classification Name: Classification:
;
Mentor Absorbent Drape Surgical Drape Class II per 21 CFR 878.4370
Manufacturer
Mentor 3000 Longwater Drive Norwell, MA 02061
Substantial Equivalence Claim
antian Equivalence Chain.
The Mentor Absorbent Drape is equivalent to operating room towels and The Menton Absorbent Bropent properties, such as the American surgical drapes with about bellight proposable of the Johnson Sof-Wick Lap Pad.
1
Indications For Use
The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
Device Description
The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.
Summary of Testing
The Mentor Absorbent Drape was tested for absorbency and found to absorb at least 100 cc per ft2 of saline solution without leaking. The absorbent material did not leak out of the pad.
The Mentor Absorbent Drape was tested for strength under simulated clinical use conditions and was found to not rip, tear or separate during the testing.
0000000
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Ophthalmics, Incorporated 5425 Hollister Avenue Santa Hollister, California 93111
K973146 Re : Mentor Sterile Absorbent Drape Trade Name: Requlatory Class: II Product Code: KKX Dated: October 30, 1997 Received: November 3, 1997
Dear Ms. Crawford:
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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
DEC - 4 1997
3
Page 2 - Ms. Crawford
through 542 of the Act for devices under the Electronic enroagle of on on on on one 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
4
K97314//p
DEC - 4 1997
510(k) SUMMARY MENTOR ABSORBENT DRAPE
This 510(k) summary of safety and effectiveness information is being submitted
This 510(k) summary of safety and effectiveness information is being and summary of surely and equirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K973146
Submitter/ Donna A. Crawford Contact Person: Manager, Corpporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111
(805) 681-6000 Telephone: (805) 681-6004 FAX:
October 28, 1997 Date Prepared:
Device Name and Classification
Proprietary Name: Common/Classification Name: Classification:
;
Mentor Absorbent Drape Surgical Drape Class II per 21 CFR 878.4370
Manufacturer
Mentor 3000 Longwater Drive Norwell, MA 02061
Substantial Equivalence Claim
antian Equivalence Chain.
The Mentor Absorbent Drape is equivalent to operating room towels and The Menton Absorbent Bropent properties, such as the American surgical drapes with about bellight proposable of the Johnson Sof-Wick Lap Pad.
5
Indications For Use
The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
Device Description
The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.
Summary of Testing
The Mentor Absorbent Drape was tested for absorbency and found to absorb at least 100 cc per ft2 of saline solution without leaking. The absorbent material did not leak out of the pad.
The Mentor Absorbent Drape was tested for strength under simulated clinical use conditions and was found to not rip, tear or separate during the testing.
0000000
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Ophthalmics, Incorporated 5425 Hollister Avenue Santa Hollister, California 93111
K973146 Re : Mentor Sterile Absorbent Drape Trade Name: Requlatory Class: II Product Code: KKX Dated: October 30, 1997 Received: November 3, 1997
Dear Ms. Crawford:
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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
DEC - 4 1997
7
Page 2 - Ms. Crawford
through 542 of the Act for devices under the Electronic enroagle of on on on on one 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
8
510(k) Number (if known):
Device Name: MENTOR Super Absorbent Drape
Indications For Use:
The Super Absorbent Drape is used to absorb fluids during surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Division of D and Gan 510(k) Numb
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use X
(Optional Format 1-2-96)