(104 days)
The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
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.
Acceptance Criteria and Device Performance Study for Mentor Absorbent Drape
This summary details the acceptance criteria and the study proving the Mentor Absorbent Drape meets these criteria, based on the provided 510(k) summary (K973146).
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Absorbency: Absorb at least 100 cc per ft² of saline solution without leaking. | Absorbency: "The Mentor Absorbent Drape was tested for absorbency and found to absorb at least 100 cc per ft² of saline solution without leaking." |
| Material Integrity (Absorbent material): Absorbent material does not leak out of the pad. | Material Integrity (Absorbent material): "The absorbent material did not leak out of the pad." |
| Strength: Does not rip, tear, or separate under simulated clinical use conditions. | Strength: "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." |
2. Sample Size and Data Provenance
The provided document does not specify the exact sample sizes used for the absorbency and strength tests. It simply states that the "Mentor Absorbent Drape was tested."
The data provenance is internal to the manufacturer (Mentor Corporation), and the tests were likely conducted prospectively as part of the device development and regulatory submission process. There is no information regarding the country of origin of the data beyond the manufacturer's location in the USA.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" for the absorbency or strength tests. These tests appear to be objective, quantitative measurements against predefined physical criteria rather than expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a surgical drape, and its performance is evaluated based on physical properties rather than diagnostic accuracy or human interpretation.
6. Standalone Performance Study
Yes, a standalone study was presented. The "Summary of Testing" describes the performance of the Mentor Absorbent Drape itself against the specified criteria for absorbency and strength. These tests were conducted on the device without human interaction being a variable in the performance measurement.
7. Type of Ground Truth Used
The ground truth used for these tests was objective, quantitative criteria for physical performance.
- For absorbency: A specific volume (100 cc) and area (per ft²) of saline solution, and the absence of liquid leakage.
- For strength: The absence of ripping, tearing, or separation under simulated clinical use conditions.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical drape), not an algorithm or AI model that requires a "training set" in the computational sense. The testing described focuses on the physical properties of the manufactured product.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The specifications for performance (e.g., 100 cc/ft² absorbency) would have been established through engineering design requirements, industry standards for surgical drapes, and potentially comparison to predicate devices, but not through a "ground truth" establishment process for a training set.
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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)
§ 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.