(96 days)
Not Found
No
The device description and performance studies focus on material properties and barrier function, with no mention of AI or ML.
No.
The device is described as a protective equipment covering to isolate equipment from contamination and is used in the OR to prevent the transfer of microorganisms, body fluids, and particulates. It does not treat or cure any medical condition.
No
Explanation: The device is described as a protective equipment covering used to isolate equipment from contamination and is used in the OR as a protective covering for operating equipment. Its function is barrier protection, not diagnosis.
No
The device is a physical equipment cover made of polyethylene and polypropylene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "protective equipment covering" to "isolate equipment from microbial and other contamination." This is a barrier function for equipment, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces its use as a "protective covering, for the operating equipment, from the transfer of microorganisms, body fluids and particulates." Again, this describes a physical barrier for equipment.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on barrier properties, strength, flammability, linting, and sterility – all characteristics relevant to a protective covering, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This equipment cover does not fit that description.
N/A
Intended Use / Indications for Use
Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.
The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
Product codes (comma separated list FDA assigned to the subject device)
KKX
MMP
Device Description
Exact Medical Manufacturing Equipment Cover- Polyethylene are single use, disposable equipment cover used in the OR as a protective covering, for the operating equipment, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Equipment Covers - Polyethylene are comprised Polyethylene with absorbent polypropylene. The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
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 Equipment Cover- Polyethylene is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K083234. Non-clinical performance testing includes: barrier properties- Level 3, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria.
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.
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
xact Medical Manufacturing, Inc.
Sec. 6 510(k) Summary – EMM Equipment Cover- Polyethylene
510(k) Summary for Exact Medical Manufacturing Inc., EMM Equipment Cover–Polyethylene :
| Date Summary was Prepared | June 10, 2010 | Exact Medical Manufacturing - Equipment
Cover - Polyethylene | Substantially
Equivalent | Kimberly-Clark KC-100 Surgical Drapes
& Equipment Covers - K083234
PREDICATE DEVICE |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Indications for Use: Exact Medical
Manufacturing Equipment Cover -
Polyethylene are sterile single use devices
made of natural or synthetic materials
intended to be used as a protective equipment
covering, such as to isolate equipment from
microbial and other contamination.
The Exact Medical Manufacturing Equipment
Covers-Polyethylene are also sold as bulk
non-sterile, single use items, to
repackager/relabeler establishments for
further packaging and ethylene oxide
sterilization. | Substantially
Equivalent | Intended Use: Kimberly-Clark intends to
market the sterile KC100 Surgical
Equipment Covers which are protective
barrier covers that are intended to be used
to cover surgical equipment and provide a
protective barrier for that equipment. |
| 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 | Classification and Code: Code KKX,
21CFR878.4370, Class II | Substantially
Equivalent | Classification & Code, Class II, MMP |
| Device Common Name | Equipment Cover | Materials & Construction: Polyethylene,
absorbent polypropylene | Substantially
Equivalent | Materials & Construction: Blue
polyethylene, with air laid reinforcement |
| Trade Name | Equipment Cover- Polyethylene, Model # 14-001 | Sterile: ISO 11135-1:2007, Sterilization of
health care products - Ethylene oxide - Part 1 | Substantially
Equivalent | Sterile |
| Device Product Codes and | MMP, 21CFR878.4370, Surgical Drape and Drape accessories, Class II | Sterile Packaging: Chevron peel pouch
(coated paper (73gsm), PET12/PE40 film
construction), individual CSR internal wrap | Substantially
Equivalent | Sterile Packaging: Chevron peel pouch
(coated paper, PE film construction),
individual CSR internal wrap |
| Classification Name | | Non-Sterile | Substantially
Equivalent | Non-Sterile |
| Predicate Device | K083234 Kimberly-Clark KC100 Surgical Drapes and Equipment Covers | Barrier properties - AATCC 42:2007,
AATCC 127:2008: Liquid Barrier Performance
and Classification of Protective Apparel and
Drapes intended for Use in Health Care
Facilities, AAMI PB70:2003 /(R)2009), Level 3
compliant | Substantially
Equivalent | Barrier properties: References AATCC
127:2008, INDA IST 80.6 (98), ISO 811-
1981, ISO 139-1973 |
| Device Description | Exact Medical Manufacturing Equipment Cover- Polyethylene are single
use, disposable equipment cover used in the OR as a protective covering,
for the operating equipment, from the transfer of microorganisms, body
fluids and particulates. Exact Medical Manufacturing Equipment Covers -
Polyethylene are comprised Polyethylene with absorbent polypropylene.
The Exact Medical Manufacturing Equipment Covers-Polyethylene are also
sold as bulk non-sterile, single use items, to repackager/relabeler
establishments for further packaging and ethylene oxide sterilization. | Tear strength - ASTM D5587-08 (no rev.)
Standard Test Method for Tearing Strength of
Fabrics by Trapezoid Procedure. Tear
strength for Md and Cd within general
industry tolerance of +/- 20% | Substantially
Equivalent | Tensile strength: NFPA 1999, 1997, ASTM
D5733-99:2002, ASTM D1004-03:2003 |
| Intended Use | Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile
single use devices made of natural or synthetic materials intended to be
used as a protective equipment covering, such as to isolate equipment from
microbial and other contamination. The Exact Medical Manufacturing
Equipment Covers-Polyethylene are also sold as bulk non-sterile, single
use items, to repackager/relabeler establishments for further packaging and
ethylene oxide sterilization | Tensile strength - ASTM D5034-09 (no rev.)
Standard Test Method for Breaking Strength
and Elongation of Textile Fabrics (Grab Test)
Tensile strength for Md and Cd within
general industry tolerance of +/- 20% | Substantially
Equivalent | Grab Test: ASTM D 5034-95: 2001 |
| Technological Characteristics | Exact Medical Manufacturing Equipment Cover- Polyethylene has the same
design, material and performance characteristics of the predicate device.
Additional Summary and explanation of technological characteristics
is included in the following Addendum A. | Flammability - 16CFR1610:2010,
Flammability of Clothing Textiles, Class 1
PASS | Substantially
Equivalent | Flammability: 16CFR1610 |
| Summary of Testing | Exact Medical Manufacturing Equipment Cover- Polyethylene is
substantially equivalent and meets the same acceptance criteria as the
predicate device/gown in K083234. Non-clinical performance testing
includes: barrier properties- Level 3, tensile, tear strength, flammability,
linting and sterility. All results of the testing met acceptance criteria.
Additional Summary and explanation of non-clinical testing is
included in the following Addendum B. | Lint and other particles generation in the dry
state - ISO 9073-10:2003 | Not Applicable | No test |
| Substantial Equivalence | The equipment covers described in this 510(k) submission are substantially
equivalent in all specifications and performance compared to the predicate
device indentified in K083234 except for minor variations in the widths and
lengths. | | | |
1
Addendum A.
:
Sec. 10: EQUIPMENT COVER Polyethylene - Predicate Device Comparison Table
•
2
Addendum B
Non-Clinical Testing Summary: EMM Equipment Cover, Model # 14-001
·
.
| Test
Article | Finished
Good Lot
Number | Reference
Standard(s) | Description | Accept - Reject
Criteria | Pass/
Fail | Test Lab |
|--------------------------------|--------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------|
| Model No.
14-001
Sterile | 0980APA3 | AATCC 42:2007
(AAMI PB70:2003
/(R)2009) | Water Resistance: Impact
Penetration Test, Level 3 | 50 cm
hydrostatic
resistance | Pass | Nelson Labs,
Utah, USA |
| Model No.
14-001
Sterile | 0980APA3 | 16CFR1610:2010 | Flammability of Clothing Textiles
- Class 1 | Class 1 =/> 3.5 sec.
average flame
spread | Pass | Nelson Labs,
Utah, USA |
| Model No.
14-001
Sterile | 0980APA3 | ASTM D5587-08
(no rev.) | Standard Test Method for
Tearing Strength of Fabrics
by Trapezoid Procedure | Acceptance criteria
not established in
recognized
standard. Tear
Strength for Md and
Cd within general
industry tolerance of
+/- 20% | Pass | Nelson Labs,
Utah, USA |
| Model No.
14-001
Sterile | 0980APA3 | ASTM D5034-09
(no rev.) | Standard Test Method for
Breaking Strength and
Elongation of Textile Fabrics
(Grab Test) | Acceptance criteria
not established in
recognized
standard. Tensile
Strength for Md and
Cd within general
industry tolerance of
+/- 20% | Pass | Nelson Labs,
Utah, USA |
| Model No.
14-001 | | ISO 11135-1:2007 | Sterilization of health care
products - Ethylene oxide - Part
1 | SAL of > 10-6 | Pass | SCDC, Shanghai,
CN LexaMed,
Ohio, USA |
| Model No.
14-001
Sterile | 0980APA3 | ISO 9073-10:2003 | Lint and other particles
generation in the dry state | Acceptance criteria
not established in
the recognized
standard | Pass | Nelson Labs,
Utah, USA |
:
.
:
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Exact Medical Manufacturing, Incorporated C/O Mr. Robert O. Dean Compliance Systems International, LLC 1083 Delaware Avenue Buffalo, New York 14209
SEP 2 0 2016
Re: K101689
Trade/Device Name: Exact Medical Manufacturing Equipment Cover-Polyethylene, Model # 14-001 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: August 20, 2010 Received: August 23, 2010
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 prémarket 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.
4
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 (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), 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. owens
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
Enclosure
5
Sec. 7: Intended Use
KID1689
Indications for Use Form
SEP 2 0 2010
Indications for Use:
510(k) Number (if known): K101689
Device Name: Exact Medical Manufacturing Equipment Cover -- Polyethylene, Model #14-001
Indications for Use: Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.
The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Edith H. Claussen-Williams
ion Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101689