(96 days)
No
The device description and performance studies focus on material properties and barrier function, with no mention of AI/ML or related concepts like image processing or data analysis.
No
The device is a surgical drape intended to be used as a protective patient covering to isolate a surgical site from contamination, not to treat a disease or condition.
No
The device is described as a "protective patient covering" for isolating a surgical site, with no mention of diagnosing conditions.
No
The device is a physical surgical drape made of materials like Spunlace and Polyethylene, 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 patient covering" used to "isolate a site of surgical incision from microbial and other contamination." This describes a physical barrier used during a medical procedure on a patient.
- Device Description: The description reinforces this by detailing the materials used to create a physical drape.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on analyzing biological samples.
Therefore, the Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides is a medical device used in vivo (on the patient's body) during surgery, not an IVD.
N/A
Intended Use / Indications for Use
Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides 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 Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
Product codes
KKX
Device Description
Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides 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 Drapes-Spunlace w/PE Sides are comprised of Spunlace, Polyethylene, 3M Medical Adhesive Tape.
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
Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties, Level 2, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria.
Summary of Non-Clinical Testing:
- Water Resistance: Impact Penetration Test, Level 3 (AATCC 42:2007 (AAMI PB70:2003 /(R)2009)), Passed, Nelson Labs, Utah, USA.
- Water Resistance: Hydrostatic Pressure Test, Level 3 (AATCC 127:2008 (AAMI PB70:2003 /(R)2009)), Passed, Nelson Labs, Utah, USA.
- Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999), Passed, LexaMed, Ohio, USA.
- Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity (Skin Irritation) (ISO 10993-10:2002), Passed, LexaMed/NAMSA, Ohio, USA.
- Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (Skin Sensitization) (ISO 10993-10:2002), Passed, LexaMed/NAMSA, Ohio, USA.
- Flammability of Clothing Textiles - Class 1 (16CFR1610:2010), Passed, Nelson Labs, Utah, USA.
- Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure (ASTM D5587-08 (no rev.)), Passed, Nelson Labs, Utah, USA.
- Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) (ASTM D5034-09 (no rev.)), Passed, Nelson Labs, Utah, USA.
- Sterilization of health care products - Ethylene oxide - Part 1 (ISO 11135-1:2007), Passed, SCDC, Shanghai, CN LexaMed, Ohio, USA.
- Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008), Passed, GOALS Sterilization Co. Jiaxing, CN.
- Lint and other particles generation in the dry state (ISO 9073-10:2003), Passed, Nelson Labs, Utah, USA.
Key Metrics
Not Found
Predicate Device(s)
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
SEP 2 0 2010
EMM al Manutacturing, Inc
Sec. 6 510(k) Summary – EMM Surgical Drape-Spunlace w/PE Sides
510(k) Summary for Exact Medical Manufacturing Inc., EMM Surgical Drape-Spunlace w/PE Sides
| Date Summary was Prepared | June 10,2010 | |
|---|---|---|
| 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 | ||
| 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 | ||
| Device Common Name | Surgical Drape | |
| Trade Name | EMM Surgical Drape-Spunlace w/PE Sides, Model 13-004 | |
| Device Product Codes and Classification | ||
| Name | KKX, 21CFR878.4370, Surgical Drape and Drape Accessories, Class II | |
| Predicate Device | Medline (Proxima) Surgical Drapes 510(k)964142 | |
| Device Description | Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides 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 Drapes-Spunlace w/PE Sides are
comprised of Spunlace, Polyethylene, 3M Medical Adhesive Tape. | |
| Intended Use | Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides 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 Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides are
also sold as bulk non-sterile, single use items, to repackager/relabeler
establishments for further packaging and ethylene oxide sterilization. | |
| Technological Characteristics | Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides 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 | |
| Summary of Testing | Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides are
substantially equivalent and meet the same acceptance criteria as the
predicate device/gown in K964142 Non-clinical performance testing
includes:
Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the
methods of ISO 10993, Barrier properties, Level 2, 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. | |
| 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 K964142 except for minor variations in the widths and
lengths. | |
| Exact Medical Manufacturing - Surgical Drape-
Spunlace w/PE Sides
Model #13-004 | Substantially
Equivalent | PREDICATE DEVICE
Medline (Proxima) Surgical Drapes
510(k)964142 |
| Indications for Use: Exact Medical Manufacturing
Surgical Drape -Spunlace w/PE Sides 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 Exact Medical Manufacturing Surgical Drape-
Spunlace w/PE Sides are also sold as bulk non-sterile,
single use items, to repackager/relabeler
establishments for further packaging and ethylene oxide
sterilization. | Substantially
Equivalent | Indications for 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. |
| Classification & Code: KKX, Surgical Drapes,
21CFR878.4370, Class II | Substantially
Equivalent | Classification & Code: KKX, Surgical
Drapes, 21CFR878.4370, Class II |
| Materials & Construction: Spunlace, Polyethylene,
Absorbent Reinforcement, 3M Medical adhesive tape | Substantially
Equivalent | Materials & Construction: Spunlace,
Absorbent reinforcement with impervious
polyethylene backing, 3M Medical adhesive
tape |
| 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,
'el 2
Electrostatic Head = 231 cm PASS | Substantially
Equivalent | Hydrostatic head = 19.5 cm |
| Sterile (via EO Gas) ISO 11135-1:2007, Sterilization of
health care products - Ethylene oxide - Part 1 | Not Applicable | |
| Sterile Packaging: Chevron peel pouch (coated paper
(73gsm), PET12/PE40 film construction), individual
CSR internal wrap | Not Applicable | Not Applicable |
| Non-sterile | Substantially
Equivalent | Non-sterile |
| Biocompatibility: cytotoxicity, irritation and
sensitization - ISO 10993-5:1999, Cytotoxicity, ISO
10993-10:2002, Skin Irritation, ISO 10993-10:2002,
Sensitization
Cytotoxicity, Irritation, Sensitization test PASS | Substantially
Equivalent | Biocompatibility: Cytotoxicity, Irritation,
Sensitization; PASS |
| Tear strength - ASTM D5587-08 (no rev.) Standard
Test Method for Tearing Strength of Fabrics by
Trapezoid Procedure
Tear strength for Md and Cd exceeds predicate
performance | Substantially
Equivalent | Md = 2.5 lbs
Cd= 1.4 lbs |
| 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 exceeds predicate
performance | Substantially
Equivalent | Md = 23 lbs
Cd = 12.1 lbs |
| Flammability - 16CFR1610:2010, Flammability of
Clothing Textiles
Class 1 - PASS | Substantially
Equivalent | Class 1 |
| Lint and other Particles generated in the dry state - | Not Applicable | No Test |
4917 William Street, Suite C, Lancaster, New York 14086 USA telephone (716) 681-0866 fax (716) 681-4110
1
Addendum A Summary and Explanation of Technical Characteristics: EMM SURGICAL DRAPE Spunlace w/PE Sides Predicate Device Comparison Table
.
2
Addendum B
Non-Clinical Testing Summary: EMM Surgical Drape – Spunlace w/PE Sides, Model # 13-004
| Test
Article | Finished
Good Lot
Number | Reference
Standard(s) | Description | Accept - Reject
Criteria | Pass/
Fail | Test Lab |
|--------------------------------|--------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------|
| Model
No. 13-004
Sterile | 0980APA2 | 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.13-004
Sterile | 0980APA2 | ISO 10993-5:1999 | Biological evaluation of medical
devices -- Part 5: Tests for in
vitro cytotoxicity | Evidence of cell lysis
or toxicity 3.5 sec.
average flame
spread | Pass | Nelson Labs,
Utah, USA |
| Model
No. 13-004
Sterile | 0980APA2 | ASTM D5587-08
(no rev.) | Standard Test Method for
Tearing Strength of Fabrics by
Trapezoid Procedure | Acceptance criteria
not established in
recognized
standard. Exceeds
predicate
performance | Pass | Nelson Labs,
Utah, USA |
| Model
No.13-004
Sterile | 0980APA2 | 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. Exceeds
predicate
performance | Pass | Nelson Labs,
Utah, USA |
| Model
No. 13-004 | 0980APA2 | 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. 13-004
Sterile | 0980APA2 | ISO 10993-7:2008 | Biological Evaluation of Medical
Devices - Part 7: Ethylene
Oxide Sterilization Residuals | Average daily dose
of EO/ECH shall not
exceed 4mg/9mg | Pass | GOALS
Sterilization Co.
Jiaxing, CN |
| Model
No.13-004
Sterile | 0980APA2 | 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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 2010
Re: K101688
Trade/Device Name: Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides, Model 13-004 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 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.
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 (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Graham
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
Indications for Use Form
SEP 2 0 2010
Indications for Use:
510(k) Number (if known): K101688
Device Name: Exact Medical Manufacturing Surgical Drape – Spunlace w/PE Sides, Model 13-004
Indications for Use: Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides 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 Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides are also sold as bulk non-sterile, 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 X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Eliz. 476. F. Claverie-Well
1 (Division Sign-Off)
(Division of Anesthesiology. General Hospital
Division of Anesthesiology. General Devices Division of Anesthestology .
Infection Control, Dental Devices
510(k) Number: