(227 days)
No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.
No.
The device, a surgical drape, is intended to be a protective covering to isolate a surgical site from contamination, not to provide therapy.
No
The device is a surgical drape intended to protect patients and isolate a surgical incision site, not to diagnose a condition.
No
The device description clearly states it is a physical surgical drape made of natural or synthetic materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during surgical procedures.
- Device Description: The description details the materials and construction of a surgical drape, focusing on its barrier properties.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) as a physical barrier.
N/A
Intended Use / Indications for Use
Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices 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 EMM Surgical Drapes AAMI Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007.
Product codes
KKX
Device Description
Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices 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.
Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level The base sheet fabric is a three layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers are thermally bonded together producing a single layer with various basis weights. The outer layers are non woven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalent and meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Barrier Performance: AAMI PB70: Level 4. ASTM F1670 - 08, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
Biocompatibility: ISO 10993-5:2009 Cytotoxicity, ISO 10993-10:2002, Skin Irritation, ISO 10993-10:2002, Sensitization
Tear strength - ASTM 5587-08 (no rev.) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure 19.4 lbs & 9.7 lbs
Breaking strength - ASTM D5034-09 (no rev.) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) 24.4 lbs & 15.9 lbs
Flammability - 16CFR1610:2007, Flammability of Clothing Textiles - Class 1
Linting - ISO 9073-10:2003, Lint and other particles generated in the dry state
Predicate Device(s)
Kimberly Clark Corporation Surgical Drapes with AAMI Liquid Barrier Level 4 claim - K102666
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K121919
| Date Summary was Prepared | Sec. 6: 510(k) Summary - EMM Surgical Drape with AAMI Liquid Barrier Level IV | Exact Medical Manufacturing Surgical Drape with AAMI
Liquid Barrier Level IV | Substantially
Equivalent | Kimberly Clark Corporation
Surgical Drapes with AAMI Liquid Barrier Level 4 claim
510(k)102666
PREDICATE DEVICE |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| June 26, 2012 | | Intended Use: Exact Medical Manufacturing Surgical Drape
AAMI Level 4 are sterile or non-sterile single use devices
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
EMM Surgical Drapes AAMI Level 4 are also sold as bulk
non-sterile, single use items, to repackager/relabeler
establishments for further packaging and ethylene oxide
sterilization according to ISO 11135-1:2007. | Substantially
Equivalent | Intended Use: The Kimberly-Clark* Surgical Drapes with AAMI
Liquid Barrier Level 4 claim are devices made of natural or
synthetic material intended to be used as a protective patient
covering, such as to isolate a site of surgical incision from
microbial and other contamination. These drapes meet the Level
4 requirements of the AAM! Liquid Barrier Classifications. The
Kimberly-Clark" Surgical Drapes with AAMI Liquid Barrier Level
4 claim are also sold as bulk non-sterite, single use items, to
repackager/relabeler establishments for further packaging and
Ethylene Oxide (EtO) sterilization. |
| 510(k) Submitter | David Nowicki, President
Exact Medical Manufacturing Inc.
4917 William Street, Suite C
Lancaster, NY 14086
dnowicki@exactmm.com
(p)716-681-0866, (f) 716-681-4110
FEB 14 2013 | Classification & Code: Surgical Drapes and Drape
Accessories, KKX, 21CFR878.4370, Class II | Substantially
Equivalent | Classification & Code: Surgical Drapes and Drape Accessories,
KKX, 21CFR878.4370, Class II |
| Primary Contact for this 510(k)
Submission | David Nowicki, President
Exact Medical Manufacturing Inc.
4917 William Street, Suite C
Lancaster, NY 14086
dnowicki@exactmm.com
(p)716-681-0866, (f) 716-681-4110 | Single Use - Disposable | Substantially
Equivalent | Single Use - Disposable |
| Device Common Name | Surgical Drape | Barrier Performance: AAM! PB70: Level 4. ASTM F1670 -
08, Standard Test Method for Resistance of Materials Used in
Protective Clothing to Penetration by Synthetic Blood | Substantially
Equivalent | Barrier Performance: AAMI PB70: Level 4 |
| Trade Name | Surgical Drape with AAMI Liquid Barrier Level IV | Materials & Construction: The base sheet fabric is a three
layer composite comprised of polypropylene spunbond and a
co-extruded PE film. Layers are thermally bonded together
producing a single layer with various basis weights. The outer
layers are non-woven fabric, the inner layer is AAMI PB:70
Level 4 capable PE film. | | Materials & Construction:
The base sheet fabric is a three layer laminate
comprised of polypropylene spunbond / polypropylene
meltblown/polypropylene spunbond. Layers are thermally
embossed together producing a single layer with varlous basis
weights. Fabric is topically treated to enhance water repellency
and to assure static dissipation. |
| Device Product Codes and
Classification Name | KKX, 21CFR878.4370, Surgical Drape and Drape Accessories | Materials Weight per square meter
Weight/m2
PN
Ref.
Description
112005196-961
1
196cm/PMC04/Blue SMS
43
2
213408097
97cm/PMC02 BiLam Mtl
45
3
213408152
152cm/ BiLam Mtl
45
4
210401148-900 PSB3030 Pad
80
4
PE
25 | Substantially
Equivalent | Unknown |
| Predicate Device | Kimberly Clark Corporation Surgical Drapes with AAMI Liquid Barrier Level 4 claim - K102666 | Color: Blue
Dye: Blue Colorant B373 (FB 1007) | | Color: Blue
Dye: Unknown |
| Device Description | Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices
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.
Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level The base sheet fabric is a
three layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers are
thermally bonded together producing a single layer with various basis weights. The outer layers are non
woven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film. | Sterile (via EO Gas) ISO 11135-1:2007, Sterilization of health
care products - Ethylene oxide - Part 1 | Substantially
Equivalent | Sterile via EO Gas |
| Intended Use | Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices
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 EMM Surgical Drapes AAMI
Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for
further packaging and ethylene oxide sterilization according to ISO 11135-1:2007 | Sterile Packaging: Chevron peel pouch (coated paper
(73gsm), PET12/PE40 film construction), individual CSR
Internal wrap | Substantially
Equivalent | Flexible unit pouch |
| Technological Characteristics | Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV has the same design,
material and performance characteristics and intended use as the predicate device. | Non-Sterile bulk pack (alternate offering) | Substantially
Equivalent | Non-sterile built pack |
| Summary of Testing | Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalent
and meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinical
performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the
methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting
and sterility. All results of the testing met acceptance criteria. | Biocompatibility: ISO 10993-5:2009 Cytotoxicity, ISO
10993-10:2002, Skin Irritation, ISO 10993-10:2002,
Sensitization | Substantially
Equivalent | tested for biocompatibility using cytotoxicity, primary skin irritation
tests and sensitization testing. |
| Substantial Equivalence | The surgical Drapes described in this 510(k) submission are substantially equivalent in all specifications
and performance compared to the predicate device indentified in K102666. | Tear strength - ASTM 5587-08 (no rev.) Standard Test
Method for Tearing Strength of Fabrics by Trapezoid
Procedure
19.4 lbs & 9.7 lbs | Substantially
Equivalent | Tear strength - Unknown |
| Breaking strength - ASTM D5034-09 (no rev.) Standard Test
Method for Breaking Strength and Elongation of Textile
Fabrics (Grab Test)
24.4 lbs & 15.9 lbs | Substantially
Equivalent | Breaking strength - unknown | | |
| Flammability - 16CFR1610:2007, Flammability of Clothing
Textiles - Class 1 | Substantially
Equivalent | Class 1 | | |
| Linting - ISO 9073-10:2003, Lint and other particles
generated in the dry state | Substantially
Equivalent | Linting - Unknown | | |
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:
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and appears to be part of a document or header. The words are all capitalized and evenly spaced.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14. 2013
Exact Medical Manufacturing, Incorporated C/O Mr. Robert O. Dean President Compliance Systems International, Limited Liability Company 1083 Delaware Avenue BUFFALO NY 14209
Re: K121919
Trade/Device Name: Exact Medical Manufacturing Surgical Drape with AAMI Level IV Liquid Barrier, Model #20-121, Blue Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 7, 2013 Received: January 30, 2013
Dear Mr. Dean:
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.
3
Page 2 - Mr. Dean
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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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), please 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/Safety/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S. Runner
Susan Runner, DDS, MA 2013.02.21
DE
13:25:05 -05'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
Indications for Use:
510(k) Number (if known): K121919
Device Name: Exact Medical Manufacturing Surgical Drape with AAMI Level IV Liguid Barner, Model # 20-
indications for Use: Exact Medical Marifacturing Surgical Drape AAM Level 4 are sterile or nor-sterile single
use to isolate a site of synthel in the fitter for a protective hareering of ose: Lack Medical Manufacturing Surgical Drape AAM Level 4 are sterile single
use devices made of natural of surgical interials intended be used as a protect as to hoo made of hautal of your microbial and obsert as a proceded as a procession of non-sterile sim
as to isolate a site of surgical internal intercolal and oble conservat സംഘം പോൾ സ്വീഫ Indical indical increase and contrastion. The Easter Covering succession The Florical Covering, Sugged Drag Claudio (Anglea Draching may for the country and ethylene oxide stenie, single use items, to repackaged to repackaged to the
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF | |
---|---|
Elizabeth F. Claverie NEEDED) | |
2013.02.15 18:16:47 -05'00' | |
(Division Sign-Off) | |
Division of Anesthesiology, General Hospital nfection Control, Dental Devices | |
510(k) Number: | K121919 |