(105 days)
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.
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.
SurgiPlus Surgical Drapes are single use, disposable patient coverings. They are made of SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are available in sterile and non-sterile forms.
The provided document is a 510(k) premarket notification for surgical drapes. It primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and adherence to specific AAMI (Association for the Advancement of Medical Instrumentation) standards for liquid barrier performance.
This document does not contain information about studies involving AI/ML devices, human readers, or the establishment of ground truth by experts in a clinical context. It pertains to the physical performance characteristics of a surgical drape.
Therefore, many of the requested categories are not applicable to the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device claims to be classified as Level 3 or Level 4 per AAMI Standard PB70 for liquid barrier performance. The document doesn't explicitly list a table of acceptance criteria and reported performance for the device against those criteria in a comparative format. Instead, it states the classification. To fully answer this, one would need to refer to AAMI Standard PB70. However, the FDA's acceptance of the 510(k) implies that the device meets the stated AAMI levels.
| Acceptance Criteria (AAMI PB70) | Reported Device Performance |
|---|---|
| Liquid Barrier Performance | |
| Level 3 or 4 | Meets Level 3 or Level 4 |
| (Specific performance metrics within AAMI PB70 - e.g., Hydrostatic Pressure, Impact Penetration Resistance) | (Implicitly meets these if classified Level 3 or 4) |
| Material Composition | SMS base sheet with SPP with PE reinforcement (for most products); SMS base sheet (for some products) |
| Intended Use | Single-use, disposable patient coverings to isolate surgical incision sites from microbial and other contaminations |
| Sterilization Status | Sterile (for product codes ending in -S) or Bulk Non-Sterile (for product codes ending in -B, for repackagers/relabelers) |
The remaining questions are largely not applicable (N/A) to this 510(k) submission because it describes the physical properties and intended use of surgical drapes, not an AI/ML diagnostic or therapeutic device that would involve clinical image analysis or human-in-the-loop performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a physical product (surgical drape) and the assessment relates to its material properties and barrier performance according to AAMI standards. There is no "test set" of clinical data to analyze. Testing would involve material samples for physical property assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth from clinical experts is not relevant for the classification of a surgical drape based on AAMI liquid barrier performance standards. The "ground truth" would be the results of standardized physical tests performed by qualified lab personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This device is a surgical drape, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a surgical drape, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the AAMI liquid barrier performance, the "ground truth" would be established by standardized laboratory testing protocols as defined by AAMI PB70. This involves objective physical measurements (e.g., hydrostatic pressure, impact penetration) rather than expert consensus on clinical data.
8. The sample size for the training set
- N/A. This is a physical product (surgical drape) and does not involve AI/ML training sets.
9. How the ground truth for the training set was established
- N/A. No training set exists for this type of device.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 .
{2}------------------------------------------------
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. | ProductCode | Product Name | Drape Materials |
|---|---|---|---|
| 1 | 70-1101-S | Laparoscopic Abdominal Drape | SMS base sheet with SPP withPE reinforcement |
| 2 | 70-1102-S | Laparotomy Drape I,w/Instrument Pad. | SMS base sheet with SPP withPE reinforcement |
| 3 | 70-1103-S | Transverse Laparotomy DrapeII, w/Instrument Pad. | SMS base sheet with SPP withPE reinforcement |
| 4 | 70-1104-S | Laparoscopic CholecystectomyDrape, w/Pouches. | SMS base sheet with SPP withPE reinforcement |
| 5 | 70-1105-S | Chest/Breast Drape, (15"x 10") | SMS base sheet with SPP withPE reinforcement |
| 6 | 70-2101-S | Cardiovascular Drape (CV) | SMS base sheet with SPP withPE reinforcement |
| 7 | 70-2102-S | Femoral Angiography Drape | SMS base sheet with SPP withPE reinforcement |
| 8 | 70-2103-S | Brachial Angiography Drape | SMS base sheet with SPP withPE reinforcement |
| 9 | 70-3101-S | Cesarean Section with Pouch(C/S) | SMS base sheet with SPP withPE reinforcement |
| 10 | 70-3102-S | Cesarean Section with Pouch& Fenestration (C/S) | SMS base sheet with SPP withPE reinforcement |
| No. | Product | Product Name | Drape Materials |
| Code | |||
| 11 | 70-3103-S | Obstetrics (OB): UnderbuttocksDrape | SMS base sheet |
| 12 | 70-3104-S | Underbuttocks Drape withPouch & Port | SMS base sheet with SPP withPE reinforcement |
| 13 | 70-4101-S | Total Hip Replacement (THR)I, Hip Drape | SMS base sheet with SPP withPE reinforcement |
| 14 | 70-4102-S | Total Hip Replacement (THR)II, Hip Drape with Pouches | SMS base sheet with SPP withPE reinforcement |
| 15 | 70-4103-S | Rotator Cuff Repair, HandDrape (Upper Extremity Drape) | SMS base sheet with SPP withPE reinforcement |
| 16 | 70-4104-S | Bilateral Limb Drape | SMS base sheet with SPP withPE reinforcement |
| 17 | 70-4105-S | Beach Chair ShoulderArthroscopy Drape | SMS base sheet with SPP withPE reinforcement |
| 18 | 70-4106-S | Shoulder U Pouch | SMS base sheet with SPP withPE reinforcement |
| 19 | 70-5101-S | Knee Replacement (TKR),Knee Arthroscopy Drapew/Pouch | SMS base sheet with SPP withPE reinforcement |
| 20 | 70-5102-S | Standard Knee ExtremityDrape, (Lower ExtremityDrape) | SMS base sheet with SPP withPE reinforcement |
| 21 | 70-6101-S | Abdominal Total Hysterectomy(ATH) | SMS base sheet with SPP withPE reinforcement |
| 22 | 70-6102-S | Vaginal Total Hysterectomy(VTH), Laparoscopic PerineaPack | SMS base sheet with SPP withPE reinforcement |
| 23 | 70-6103-S | Laparoscopic Assisted VaginalHysterectomy (LAVH) | SMS base sheet with SPP withPE reinforcement |
| 24 | 70-6104-S | Tubal Ligation of Sterilization(T/S), Laparoscopy T-Drape | SMS base sheet with SPP withPE reinforcement |
| 25 | 70-6105-S | Lithotomy Drape with Pouch | SMS base sheet with SPP withPE reinforcement |
| 26 | 70-6106-S | Gynaecology set | SMS base sheet with SPP withPE reinforcement |
| 27 | 70-7101-S | Cystoscopy T Drape | SMS base sheet with SPP withPE reinforcement |
| 28 | 70-7102-S | Urological Drape | SMS base sheet with SPP withPE reinforcement |
| 29 | 70-8101-S | Intra Capsular CataractExtraction (ICCE) | SMS base sheet with SPP withPE reinforcement |
| 30 | 70-8102-S | Thyroidectomy, Thyroid T-Drape | SMS base sheet with SPP withPE reinforcement |
| 31 | 70-8103-S | Craniotomy Drape, Head | SMS base sheet with SPP withPE reinforcement |
| 32 | 70-9101-S | Extremity drape hand, 100x175 | SMS base sheet with SPP withPE reinforcement |
| 33 | 70-9102-S | Extremity drape hand, 150x180 | SMS base sheet with SPP withPE reinforcement |
| 34 | 70-9103-S | Extremity drape hand, 225x300(3 layers) | SMS base sheet with SPP withPE reinforcement |
| 35 | 71-3101-S | 3/4 sheet | SMS base sheet |
| No. | ProductCode | 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 withPE reinforcement |
| 38 | 71-3104-S | Side drape | SMS base sheet with SPP withPE reinforcement |
| 39 | 71-3105-S | Bottom Drape | SMS base sheet with SPP withPE reinforcement |
Sterile SurgiPlus SMS Surgical Drape
{3}------------------------------------------------
{4}------------------------------------------------
Non-Sterile SurgiPlus SMS Surgical Drape
| No. | ProductCode | Product Name | Drape Materials |
|---|---|---|---|
| 1 | 70-1101-B | Laparoscopic Abdominal Drape | SMS base sheet with SPP withPE reinforcement |
| 2 | 70-1102-B | Laparotomy Drape I,w/Instrument Pad. | SMS base sheet with SPP withPE reinforcement |
| 3 | 70-1103-B | Transverse Laparotomy DrapeII, w/Instrument Pad. | SMS base sheet with SPP withPE reinforcement |
| 4 | 70-1104-B | Laparoscopic CholecystectomyDrape, w/Pouches. | SMS base sheet with SPP withPE reinforcement |
| 5 | 70-1105-B | Chest/Breast Drape, (15"x 10") | SMS base sheet with SPP withPE reinforcement |
| 6 | 70-2101-B | Cardiovascular Drape (CV) | SMS base sheet with SPP withPE reinforcement |
| 7 | 70-2102-B | Femoral Angiography Drape | SMS base sheet with SPP withPE reinforcement |
| 8 | 70-2103-B | Brachial Angiography Drape | SMS base sheet with SPP withPE reinforcement |
| 9 | 70-3101-B | Cesarean Section with Pouch(C/S) | SMS base sheet with SPP withPE reinforcement |
| 10 | 70-3102-B | Cesarean Section with Pouch& Fenestration (C/S) | SMS base sheet with SPP withPE reinforcement |
| 11 | 70-3103-B | Obstetrics (OB): UnderbuttocksDrape | SMS base sheet |
| 12 | 70-3104-B | Underbuttocks Drape withPouch & Port | SMS base sheet with SPP withPE reinforcement |
| 13 | 70-4101-B | Total Hip Replacement (THR)I, Hip Drape | SMS base sheet with SPP withPE reinforcement |
| 14 | 70-4102-B | Total Hip Replacement (THR)II, Hip Drape with Pouches | SMS base sheet with SPP withPE reinforcement |
| 15 | 70-4103-B | Rotator Cuff Repair, HandDrape (Upper Extremity Drape) | SMS base sheet with SPP withPE reinforcement |
| 16 | 70-4104-B | Bilateral Limb Drape | SMS base sheet with SPP withPE reinforcement |
| 17 | 70-4105-B | Beach Chair ShoulderArthroscopy Drape | SMS base sheet with SPP withPE reinforcement |
| 18 | 70-4106-B | Shoulder U Pouch | SMS base sheet with SPP withPE reinforcement |
| 19 | 70-5101-B | Knee Replacement (TKR),Knee Arthroscopy Drapew/Pouch | SMS base sheet with SPP withPE reinforcement |
| No. | ProductCode | Product Name | Drape Materials |
| 20 | 70-5102-B | Standard Knee ExtremityDrape, (Lower ExtremityDrape) | SMS base sheet with SPP withPE reinforcement |
| 21 | 70-6101-B | Abdominal Total Hysterectomy(ATH) | SMS base sheet with SPP withPE reinforcement |
| 22 | 70-6102-B | Vaginal Total Hysterectomy(VTH), Laparoscopic PerineaPack | SMS base sheet with SPP withPE reinforcement |
| 23 | 70-6103-B | Laparoscopic Assisted VaginalHysterectomy (LAVH) | SMS base sheet with SPP withPE reinforcement |
| 24 | 70-6104-B | Tubal Ligation of Sterilization(T/S), Laparoscopy T-Drape | SMS base sheet with SPP withPE reinforcement |
| 25 | 70-6105-B | Lithotomy Drape with Pouch | SMS base sheet with SPP withPE reinforcement |
| 26 | 70-6106-B | Gynaecology set | SMS base sheet with SPP withPE reinforcement |
| 27 | 70-7101-B | Cystoscopy T Drape | SMS base sheet with SPP withPE reinforcement |
| 28 | 70-7102-B | Urological Drape | SMS base sheet with SPP withPE reinforcement |
| 29 | 70-8101-B | Intra Capsular CataractExtraction (ICCE) | SMS base sheet with SPP withPE reinforcement |
| 30 | 70-8102-B | Thyroidectomy, Thyroid T-Drape | SMS base sheet with SPP withPE reinforcement |
| 31 | 70-8103-B | Craniotomy Drape, Head | SMS base sheet with SPP withPE reinforcement |
| 32 | 70-9101-B | Extremity drape hand, 100x175 | SMS base sheet with SPP withPE reinforcement |
| 33 | 70-9102-B | Extremity drape hand, 150x180 | SMS base sheet with SPP withPE reinforcement |
| 34 | 70-9103-B | Extremity drape hand, 225x300(3 layers) | SMS base sheet with SPP withPE 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 withPE reinforcement |
| 38 | 71-3104-B | Side drape | SMS base sheet with SPP withPE reinforcement |
| 39 | 71-3105-B | Bottom Drape | SMS base sheet with SPP withPE reinforcement |
{5}------------------------------------------------
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.
{6}------------------------------------------------
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
§ 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.