SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)

K102861 · A Plus International, Inc. · KKX · Jan 13, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102861
• Device Name: SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
• Applicant: A Plus International, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jan 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations. The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Device Story

SurgiPlus Surgical Drapes are single-use, disposable patient coverings; function as physical barriers to isolate surgical incision sites from microbial and other contaminants. Constructed from SMS (spunbond-meltblown-spunbond) base sheets, some models include SPP (spunbond polypropylene) with PE (polyethylene) reinforcement. Used in operating rooms by surgical personnel. Available as sterile finished goods or bulk non-sterile items for repackaging and EtO sterilization. Protects patients by maintaining sterile fields during various surgical procedures (e.g., laparoscopy, cardiovascular, orthopedic, obstetric, gynecological, urological, ophthalmic).

Clinical Evidence

Bench testing only. Device performance evaluated against AAMI PB70 standards for liquid barrier classification (Level 3 or 4). No clinical data provided.

Technological Characteristics

Materials: SMS base sheet, SPP, PE reinforcement. Barrier performance: AAMI PB70 Level 3 or 4. Form factor: Various surgical drape configurations (e.g., laparotomy, extremity, obstetric). Sterilization: Ethylene Oxide (EtO) for sterile versions.

Indications for Use

Indicated for use by operating room personnel as protective covers to isolate surgical incision sites from microbial and other contaminations during surgical and medical procedures. Applicable to all patient populations undergoing such procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

A Plus International, Incorporated C/O Mr. Mark Job Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

JAN 1 3 2911

Re: K102861

Trade/Device Name: SurgiPlus Surgical Drapes with AAMI Liquid Barrier Level 3 or 4 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 6, 2011 Received: January 7, 2011

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Federal Register. September 1978 in the security of the state of the station of the

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Page 2- Mr. Job

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). pleáse go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
James J. Rosolack
for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health .

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## I. Indications for Use

### 510(k) Number : K102861

Device Name: SurgiPlus Surgical Drapes with AAMI Liquid Barrier Level 3 or 4 claim

### Indications for Use:

SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations. Below please find the device names, model numbers and total number of surgical drapes for this submission.

The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

The drapes are classified as Level 3 or Level 4 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

| No. | Product<br>Code | Product Name | Drape Materials |
|-----|-----------------|-------------------------------------------------------------------|--------------------------------------------------|
| 1 | 70-1101-S | Laparoscopic Abdominal Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 2 | 70-1102-S | Laparotomy Drape I,<br>w/Instrument Pad. | SMS base sheet with SPP with<br>PE reinforcement |
| 3 | 70-1103-S | Transverse Laparotomy Drape<br>II, w/Instrument Pad. | SMS base sheet with SPP with<br>PE reinforcement |
| 4 | 70-1104-S | Laparoscopic Cholecystectomy<br>Drape, w/Pouches. | SMS base sheet with SPP with<br>PE reinforcement |
| 5 | 70-1105-S | Chest/Breast Drape, (15"x 10") | SMS base sheet with SPP with<br>PE reinforcement |
| 6 | 70-2101-S | Cardiovascular Drape (CV) | SMS base sheet with SPP with<br>PE reinforcement |
| 7 | 70-2102-S | Femoral Angiography Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 8 | 70-2103-S | Brachial Angiography Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 9 | 70-3101-S | Cesarean Section with Pouch<br>(C/S) | SMS base sheet with SPP with<br>PE reinforcement |
| 10 | 70-3102-S | Cesarean Section with Pouch<br>& Fenestration (C/S) | SMS base sheet with SPP with<br>PE reinforcement |
| No. | Product | Product Name | Drape Materials |
| | Code | | |
| 11 | 70-3103-S | Obstetrics (OB): Underbuttocks<br>Drape | SMS base sheet |
| 12 | 70-3104-S | Underbuttocks Drape with<br>Pouch & Port | SMS base sheet with SPP with<br>PE reinforcement |
| 13 | 70-4101-S | Total Hip Replacement (THR)<br>I, Hip Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 14 | 70-4102-S | Total Hip Replacement (THR)<br>II, Hip Drape with Pouches | SMS base sheet with SPP with<br>PE reinforcement |
| 15 | 70-4103-S | Rotator Cuff Repair, Hand<br>Drape (Upper Extremity Drape) | SMS base sheet with SPP with<br>PE reinforcement |
| 16 | 70-4104-S | Bilateral Limb Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 17 | 70-4105-S | Beach Chair Shoulder<br>Arthroscopy Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 18 | 70-4106-S | Shoulder U Pouch | SMS base sheet with SPP with<br>PE reinforcement |
| 19 | 70-5101-S | Knee Replacement (TKR),<br>Knee Arthroscopy Drape<br>w/Pouch | SMS base sheet with SPP with<br>PE reinforcement |
| 20 | 70-5102-S | Standard Knee Extremity<br>Drape, (Lower Extremity<br>Drape) | SMS base sheet with SPP with<br>PE reinforcement |
| 21 | 70-6101-S | Abdominal Total Hysterectomy<br>(ATH) | SMS base sheet with SPP with<br>PE reinforcement |
| 22 | 70-6102-S | Vaginal Total Hysterectomy<br>(VTH), Laparoscopic Perinea<br>Pack | SMS base sheet with SPP with<br>PE reinforcement |
| 23 | 70-6103-S | Laparoscopic Assisted Vaginal<br>Hysterectomy (LAVH) | SMS base sheet with SPP with<br>PE reinforcement |
| 24 | 70-6104-S | Tubal Ligation of Sterilization<br>(T/S), Laparoscopy T-Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 25 | 70-6105-S | Lithotomy Drape with Pouch | SMS base sheet with SPP with<br>PE reinforcement |
| 26 | 70-6106-S | Gynaecology set | SMS base sheet with SPP with<br>PE reinforcement |
| 27 | 70-7101-S | Cystoscopy T Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 28 | 70-7102-S | Urological Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 29 | 70-8101-S | Intra Capsular Cataract<br>Extraction (ICCE) | SMS base sheet with SPP with<br>PE reinforcement |
| 30 | 70-8102-S | Thyroidectomy, Thyroid T-<br>Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 31 | 70-8103-S | Craniotomy Drape, Head | SMS base sheet with SPP with<br>PE reinforcement |
| 32 | 70-9101-S | Extremity drape hand, 100x175 | SMS base sheet with SPP with<br>PE reinforcement |
| 33 | 70-9102-S | Extremity drape hand, 150x180 | SMS base sheet with SPP with<br>PE reinforcement |
| 34 | 70-9103-S | Extremity drape hand, 225x300<br>(3 layers) | SMS base sheet with SPP with<br>PE reinforcement |
| 35 | 71-3101-S | 3/4 sheet | SMS base sheet |
| No. | Product<br>Code | Product Name | Drape Materials |
| 36 | 71-3102-S | 1/2 sheet | SMS base sheet |
| 37 | 71-3103-S | Top drape | SMS base sheet with SPP with<br>PE reinforcement |
| 38 | 71-3104-S | Side drape | SMS base sheet with SPP with<br>PE reinforcement |
| 39 | 71-3105-S | Bottom Drape | SMS base sheet with SPP with<br>PE reinforcement |

### Sterile SurgiPlus SMS Surgical Drape

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#

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##

### Non-Sterile SurgiPlus SMS Surgical Drape

| No. | Product<br>Code | Product Name | Drape Materials |
|-----|-----------------|-------------------------------------------------------------------|--------------------------------------------------|
| 1 | 70-1101-B | Laparoscopic Abdominal Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 2 | 70-1102-B | Laparotomy Drape I,<br>w/Instrument Pad. | SMS base sheet with SPP with<br>PE reinforcement |
| 3 | 70-1103-B | Transverse Laparotomy Drape<br>II, w/Instrument Pad. | SMS base sheet with SPP with<br>PE reinforcement |
| 4 | 70-1104-B | Laparoscopic Cholecystectomy<br>Drape, w/Pouches. | SMS base sheet with SPP with<br>PE reinforcement |
| 5 | 70-1105-B | Chest/Breast Drape, (15"x 10") | SMS base sheet with SPP with<br>PE reinforcement |
| 6 | 70-2101-B | Cardiovascular Drape (CV) | SMS base sheet with SPP with<br>PE reinforcement |
| 7 | 70-2102-B | Femoral Angiography Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 8 | 70-2103-B | Brachial Angiography Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 9 | 70-3101-B | Cesarean Section with Pouch<br>(C/S) | SMS base sheet with SPP with<br>PE reinforcement |
| 10 | 70-3102-B | Cesarean Section with Pouch<br>& Fenestration (C/S) | SMS base sheet with SPP with<br>PE reinforcement |
| 11 | 70-3103-B | Obstetrics (OB): Underbuttocks<br>Drape | SMS base sheet |
| 12 | 70-3104-B | Underbuttocks Drape with<br>Pouch & Port | SMS base sheet with SPP with<br>PE reinforcement |
| 13 | 70-4101-B | Total Hip Replacement (THR)<br>I, Hip Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 14 | 70-4102-B | Total Hip Replacement (THR)<br>II, Hip Drape with Pouches | SMS base sheet with SPP with<br>PE reinforcement |
| 15 | 70-4103-B | Rotator Cuff Repair, Hand<br>Drape (Upper Extremity Drape) | SMS base sheet with SPP with<br>PE reinforcement |
| 16 | 70-4104-B | Bilateral Limb Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 17 | 70-4105-B | Beach Chair Shoulder<br>Arthroscopy Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 18 | 70-4106-B | Shoulder U Pouch | SMS base sheet with SPP with<br>PE reinforcement |
| 19 | 70-5101-B | Knee Replacement (TKR),<br>Knee Arthroscopy Drape<br>w/Pouch | SMS base sheet with SPP with<br>PE reinforcement |
| No. | Product<br>Code | Product Name | Drape Materials |
| 20 | 70-5102-B | Standard Knee Extremity<br>Drape, (Lower Extremity<br>Drape) | SMS base sheet with SPP with<br>PE reinforcement |
| 21 | 70-6101-B | Abdominal Total Hysterectomy<br>(ATH) | SMS base sheet with SPP with<br>PE reinforcement |
| 22 | 70-6102-B | Vaginal Total Hysterectomy<br>(VTH), Laparoscopic Perinea<br>Pack | SMS base sheet with SPP with<br>PE reinforcement |
| 23 | 70-6103-B | Laparoscopic Assisted Vaginal<br>Hysterectomy (LAVH) | SMS base sheet with SPP with<br>PE reinforcement |
| 24 | 70-6104-B | Tubal Ligation of Sterilization<br>(T/S), Laparoscopy T-Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 25 | 70-6105-B | Lithotomy Drape with Pouch | SMS base sheet with SPP with<br>PE reinforcement |
| 26 | 70-6106-B | Gynaecology set | SMS base sheet with SPP with<br>PE reinforcement |
| 27 | 70-7101-B | Cystoscopy T Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 28 | 70-7102-B | Urological Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 29 | 70-8101-B | Intra Capsular Cataract<br>Extraction (ICCE) | SMS base sheet with SPP with<br>PE reinforcement |
| 30 | 70-8102-B | Thyroidectomy, Thyroid T-<br>Drape | SMS base sheet with SPP with<br>PE reinforcement |
| 31 | 70-8103-B | Craniotomy Drape, Head | SMS base sheet with SPP with<br>PE reinforcement |
| 32 | 70-9101-B | Extremity drape hand, 100x175 | SMS base sheet with SPP with<br>PE reinforcement |
| 33 | 70-9102-B | Extremity drape hand, 150x180 | SMS base sheet with SPP with<br>PE reinforcement |
| 34 | 70-9103-B | Extremity drape hand, 225x300<br>(3 layers) | SMS base sheet with SPP with<br>PE reinforcement |
| 35 | 71-3101-B | 3/4 sheet | SMS base sheet |
| 36 | 71-3102-B | 1/2 sheet | SMS base sheet |
| 37 | 71-3103-B | Top drape | SMS base sheet with SPP with<br>PE reinforcement |
| 38 | 71-3104-B | Side drape | SMS base sheet with SPP with<br>PE reinforcement |
| 39 | 71-3105-B | Bottom Drape | SMS base sheet with SPP with<br>PE reinforcement |

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#### A Plus International, Inc. SurgiPlus Surgical Drape 510(K) Premarket Submission

### Caution:

The contents of this package, as with any woven/nonwoven material, may burn if exposed to a flame or an extremely hot object. Avoid contact with an open flame or high intensity heat sources. Do not use in the presence of flammable anesthesia.

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#### A Plus International, Inc. SurgiPlus Surgical Drape 510(K) Premarket Submission

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eindith F. (Lumis) Will
(Exhibit - Sign Off)

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102861