← Product Code [KKX](/productcode/KKX) · K973146 # MENTOR SUPER ABSORBENT DRAPE (K973146) _Mentor Ophthalmics, Inc. · KKX · Dec 4, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K973146 ## Device Facts - **Applicant:** Mentor Ophthalmics, Inc. - **Product Code:** [KKX](/productcode/KKX.md) - **Decision Date:** Dec 4, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4370 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The Mentor Absorbent Drape is used to absorb fluids during surgical procedures. ## Device Story Mentor Absorbent Drape is a sterile, single-use surgical drape measuring 29 x 35 inches. It consists of a layered absorbent material sandwiched between a permeable spunbond layer and a non-permeable layer. Used in operating rooms to manage fluid during surgical procedures; helps maintain a clean surgical field by absorbing fluids and preventing leakage. The device is intended for over-the-counter use. ## Clinical Evidence Bench testing only. Absorbency testing demonstrated a capacity of at least 100 cc per ft2 of saline solution without leakage. Strength testing under simulated clinical use conditions confirmed the device does not rip, tear, or separate. ## Technological Characteristics Dimensions: 29 x 35 inches. Construction: Layered absorbent material between a permeable spunbond layer and a non-permeable layer. Sterile, single-use. No electronic or software components. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Johnson Sof-Wick Lap Pad ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) --- **Source:** [https://fda-staging.innolitics.com/device/K973146](https://fda-staging.innolitics.com/device/K973146) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com