(105 days)
Not Found
Not Found
No
The device is a surgical drape, a physical barrier, and the description contains no mention of AI or ML.
No
Surgical drapes are protective barriers used to prevent contamination during surgery, not to treat a medical condition or disease.
No
Explanation: The device, SurgiPlus Surgical Drapes, is intended to be used as protective covers to isolate surgical incision sites from microbial and other contaminations, not to diagnose a disease or condition.
No
The device is a physical surgical drape, not software. The description details materials and physical characteristics.
Based on the provided information, the SurgiPlus Surgical Drapes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide a protective barrier during surgical procedures to isolate the incision site from contamination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical materials and form of the drapes (SMS, SPP, PE, sterile/non-sterile). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Surgical drapes are considered medical devices, but they fall under a different classification than IVDs. They are typically classified based on their barrier properties and intended use in surgical settings.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
SurgiPlus Surgical Drapes are single use, disposable patient coverings. The drapes are made from SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are classified as Level 3 or Level 4 per AAMI Standard PB70. The drapes are available in various configurations for different surgical procedures, listed as both sterile and non-sterile items.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, Laparotomy, Cholecystectomy, Chest, Breast, Cardiovascular, Femoral Angiography, Brachial Angiography, Cesarean Section, Underbuttocks, Hip, Hand, Upper Extremity, Limb, Shoulder, Knee, Lower Extremity, Abdominal Total Hysterectomy, Vaginal Total Hysterectomy, Laparoscopic Perinea, Laparoscopic Assisted Vaginal Hysterectomy, Tubal Ligation of Sterilization, Lithotomy, Gynaecology, Cystoscopy, Urological, Intra Capsular Cataract Extraction, Thyroidectomy, Craniotomy, Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
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)
Not Found
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
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. | Product
Code | Product Name | Drape Materials |
|-----|-----------------|-------------------------------------------------------------------|--------------------------------------------------|
| 1 | 70-1101-S | Laparoscopic Abdominal Drape | SMS base sheet with SPP with
PE reinforcement |
| 2 | 70-1102-S | Laparotomy Drape I,
w/Instrument Pad. | SMS base sheet with SPP with
PE reinforcement |
| 3 | 70-1103-S | Transverse Laparotomy Drape
II, w/Instrument Pad. | SMS base sheet with SPP with
PE reinforcement |
| 4 | 70-1104-S | Laparoscopic Cholecystectomy
Drape, w/Pouches. | SMS base sheet with SPP with
PE reinforcement |
| 5 | 70-1105-S | Chest/Breast Drape, (15"x 10") | SMS base sheet with SPP with
PE reinforcement |
| 6 | 70-2101-S | Cardiovascular Drape (CV) | SMS base sheet with SPP with
PE reinforcement |
| 7 | 70-2102-S | Femoral Angiography Drape | SMS base sheet with SPP with
PE reinforcement |
| 8 | 70-2103-S | Brachial Angiography Drape | SMS base sheet with SPP with
PE reinforcement |
| 9 | 70-3101-S | Cesarean Section with Pouch
(C/S) | SMS base sheet with SPP with
PE reinforcement |
| 10 | 70-3102-S | Cesarean Section with Pouch
& Fenestration (C/S) | SMS base sheet with SPP with
PE reinforcement |
| No. | Product | Product Name | Drape Materials |
| | Code | | |
| 11 | 70-3103-S | Obstetrics (OB): Underbuttocks
Drape | SMS base sheet |
| 12 | 70-3104-S | Underbuttocks Drape with
Pouch & Port | SMS base sheet with SPP with
PE reinforcement |
| 13 | 70-4101-S | Total Hip Replacement (THR)
I, Hip Drape | SMS base sheet with SPP with
PE reinforcement |
| 14 | 70-4102-S | Total Hip Replacement (THR)
II, Hip Drape with Pouches | SMS base sheet with SPP with
PE reinforcement |
| 15 | 70-4103-S | Rotator Cuff Repair, Hand
Drape (Upper Extremity Drape) | SMS base sheet with SPP with
PE reinforcement |
| 16 | 70-4104-S | Bilateral Limb Drape | SMS base sheet with SPP with
PE reinforcement |
| 17 | 70-4105-S | Beach Chair Shoulder
Arthroscopy Drape | SMS base sheet with SPP with
PE reinforcement |
| 18 | 70-4106-S | Shoulder U Pouch | SMS base sheet with SPP with
PE reinforcement |
| 19 | 70-5101-S | Knee Replacement (TKR),
Knee Arthroscopy Drape
w/Pouch | SMS base sheet with SPP with
PE reinforcement |
| 20 | 70-5102-S | Standard Knee Extremity
Drape, (Lower Extremity
Drape) | SMS base sheet with SPP with
PE reinforcement |
| 21 | 70-6101-S | Abdominal Total Hysterectomy
(ATH) | SMS base sheet with SPP with
PE reinforcement |
| 22 | 70-6102-S | Vaginal Total Hysterectomy
(VTH), Laparoscopic Perinea
Pack | SMS base sheet with SPP with
PE reinforcement |
| 23 | 70-6103-S | Laparoscopic Assisted Vaginal
Hysterectomy (LAVH) | SMS base sheet with SPP with
PE reinforcement |
| 24 | 70-6104-S | Tubal Ligation of Sterilization
(T/S), Laparoscopy T-Drape | SMS base sheet with SPP with
PE reinforcement |
| 25 | 70-6105-S | Lithotomy Drape with Pouch | SMS base sheet with SPP with
PE reinforcement |
| 26 | 70-6106-S | Gynaecology set | SMS base sheet with SPP with
PE reinforcement |
| 27 | 70-7101-S | Cystoscopy T Drape | SMS base sheet with SPP with
PE reinforcement |
| 28 | 70-7102-S | Urological Drape | SMS base sheet with SPP with
PE reinforcement |
| 29 | 70-8101-S | Intra Capsular Cataract
Extraction (ICCE) | SMS base sheet with SPP with
PE reinforcement |
| 30 | 70-8102-S | Thyroidectomy, Thyroid T-
Drape | SMS base sheet with SPP with
PE reinforcement |
| 31 | 70-8103-S | Craniotomy Drape, Head | SMS base sheet with SPP with
PE reinforcement |
| 32 | 70-9101-S | Extremity drape hand, 100x175 | SMS base sheet with SPP with
PE reinforcement |
| 33 | 70-9102-S | Extremity drape hand, 150x180 | SMS base sheet with SPP with
PE reinforcement |
| 34 | 70-9103-S | Extremity drape hand, 225x300
(3 layers) | SMS base sheet with SPP with
PE reinforcement |
| 35 | 71-3101-S | 3/4 sheet | SMS base sheet |
| No. | Product
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
PE reinforcement |
| 38 | 71-3104-S | Side drape | SMS base sheet with SPP with
PE reinforcement |
| 39 | 71-3105-S | Bottom Drape | SMS base sheet with SPP with
PE reinforcement |
Sterile SurgiPlus SMS Surgical Drape
3
4
Non-Sterile SurgiPlus SMS Surgical Drape
| No. | Product
Code | Product Name | Drape Materials |
|-----|-----------------|-------------------------------------------------------------------|--------------------------------------------------|
| 1 | 70-1101-B | Laparoscopic Abdominal Drape | SMS base sheet with SPP with
PE reinforcement |
| 2 | 70-1102-B | Laparotomy Drape I,
w/Instrument Pad. | SMS base sheet with SPP with
PE reinforcement |
| 3 | 70-1103-B | Transverse Laparotomy Drape
II, w/Instrument Pad. | SMS base sheet with SPP with
PE reinforcement |
| 4 | 70-1104-B | Laparoscopic Cholecystectomy
Drape, w/Pouches. | SMS base sheet with SPP with
PE reinforcement |
| 5 | 70-1105-B | Chest/Breast Drape, (15"x 10") | SMS base sheet with SPP with
PE reinforcement |
| 6 | 70-2101-B | Cardiovascular Drape (CV) | SMS base sheet with SPP with
PE reinforcement |
| 7 | 70-2102-B | Femoral Angiography Drape | SMS base sheet with SPP with
PE reinforcement |
| 8 | 70-2103-B | Brachial Angiography Drape | SMS base sheet with SPP with
PE reinforcement |
| 9 | 70-3101-B | Cesarean Section with Pouch
(C/S) | SMS base sheet with SPP with
PE reinforcement |
| 10 | 70-3102-B | Cesarean Section with Pouch
& Fenestration (C/S) | SMS base sheet with SPP with
PE reinforcement |
| 11 | 70-3103-B | Obstetrics (OB): Underbuttocks
Drape | SMS base sheet |
| 12 | 70-3104-B | Underbuttocks Drape with
Pouch & Port | SMS base sheet with SPP with
PE reinforcement |
| 13 | 70-4101-B | Total Hip Replacement (THR)
I, Hip Drape | SMS base sheet with SPP with
PE reinforcement |
| 14 | 70-4102-B | Total Hip Replacement (THR)
II, Hip Drape with Pouches | SMS base sheet with SPP with
PE reinforcement |
| 15 | 70-4103-B | Rotator Cuff Repair, Hand
Drape (Upper Extremity Drape) | SMS base sheet with SPP with
PE reinforcement |
| 16 | 70-4104-B | Bilateral Limb Drape | SMS base sheet with SPP with
PE reinforcement |
| 17 | 70-4105-B | Beach Chair Shoulder
Arthroscopy Drape | SMS base sheet with SPP with
PE reinforcement |
| 18 | 70-4106-B | Shoulder U Pouch | SMS base sheet with SPP with
PE reinforcement |
| 19 | 70-5101-B | Knee Replacement (TKR),
Knee Arthroscopy Drape
w/Pouch | SMS base sheet with SPP with
PE reinforcement |
| No. | Product
Code | Product Name | Drape Materials |
| 20 | 70-5102-B | Standard Knee Extremity
Drape, (Lower Extremity
Drape) | SMS base sheet with SPP with
PE reinforcement |
| 21 | 70-6101-B | Abdominal Total Hysterectomy
(ATH) | SMS base sheet with SPP with
PE reinforcement |
| 22 | 70-6102-B | Vaginal Total Hysterectomy
(VTH), Laparoscopic Perinea
Pack | SMS base sheet with SPP with
PE reinforcement |
| 23 | 70-6103-B | Laparoscopic Assisted Vaginal
Hysterectomy (LAVH) | SMS base sheet with SPP with
PE reinforcement |
| 24 | 70-6104-B | Tubal Ligation of Sterilization
(T/S), Laparoscopy T-Drape | SMS base sheet with SPP with
PE reinforcement |
| 25 | 70-6105-B | Lithotomy Drape with Pouch | SMS base sheet with SPP with
PE reinforcement |
| 26 | 70-6106-B | Gynaecology set | SMS base sheet with SPP with
PE reinforcement |
| 27 | 70-7101-B | Cystoscopy T Drape | SMS base sheet with SPP with
PE reinforcement |
| 28 | 70-7102-B | Urological Drape | SMS base sheet with SPP with
PE reinforcement |
| 29 | 70-8101-B | Intra Capsular Cataract
Extraction (ICCE) | SMS base sheet with SPP with
PE reinforcement |
| 30 | 70-8102-B | Thyroidectomy, Thyroid T-
Drape | SMS base sheet with SPP with
PE reinforcement |
| 31 | 70-8103-B | Craniotomy Drape, Head | SMS base sheet with SPP with
PE reinforcement |
| 32 | 70-9101-B | Extremity drape hand, 100x175 | SMS base sheet with SPP with
PE reinforcement |
| 33 | 70-9102-B | Extremity drape hand, 150x180 | SMS base sheet with SPP with
PE reinforcement |
| 34 | 70-9103-B | Extremity drape hand, 225x300
(3 layers) | SMS base sheet with SPP with
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
PE reinforcement |
| 38 | 71-3104-B | Side drape | SMS base sheet with SPP with
PE reinforcement |
| 39 | 71-3105-B | Bottom Drape | SMS base sheet with SPP with
PE 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