(118 days)
Not Found
No
The device description and performance studies focus on material properties and barrier function, with no mention of AI/ML or related technologies.
No.
The surgical drape is intended to protect and isolate, not to provide therapy.
No
Explanation: The device is described as a surgical drape intended to be used as a protective patient covering to isolate a surgical incision site. Its function is to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is made of physical materials (SMS, PE Layer, 3M Medical Adhesive Tape) and is intended for use as a physical barrier (surgical drape). There is no mention of software components or functionality.
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 surgical procedure.
- Device Description: The description details the materials used (SMS, PE Layer, adhesive tape) and reinforces its function as a protective covering.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
Therefore, the Exact Medical Manufacturing Surgical Drape SMS w/PE Sides is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Exact Medical Manufacturing Surgical Drape SMS 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 SMS 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 (comma separated list FDA assigned to the subject device)
KKX
Device Description
Exact Medical Manufacturing Surgical Drapes Surgical Drape SMS 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 SMS w/PE Sides are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K021864. Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties AAMI PB:70 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.
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.
510(k)021864
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
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Image /page/0/Picture/1 description: The image shows a logo with a geometric design on the left and text on the right. The geometric design consists of a square divided into four quadrants, with the upper-left quadrant filled with a solid black triangle and the other quadrants filled with dots. To the right of the geometric design, the text "EMM" is displayed in bold, followed by "Exact Medical Manufacturing, Inc." in a smaller font size.
Sec. 6: 510(k) Summary - EMM Surgical Drape SMS w/PE Sides
. .
···
510(k) Summary for Exact Medical Manufacturing Inc., EMM Surgical Drape – SMS w/PE Sides
| Date Summary was Prepared | July 29, 2010 (rev.1) |
|---|---|
| 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 | |
| Lancaster, NY 14086 | |
| dnowicki@exactmm.com | |
| (p)716-681-0866, (f) 716-681-4110 | |
| Device Common Name | Surgical Drape |
| Trade Name | EMM Surgical Drape SMS w/PE Sides, Model 13-005 |
| Device Product Codes and | |
| Classification Name | KKX, 21CFR878.4370, Surgical Drape and Drape accessories, Class II |
| Predicate Device | Primeline (Primagard) Surgical drapes 510(k)021864 |
| Device Description | Exact Medical Manufacturing Surgical Drapes Surgical Drape SMS 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 SMS w/PE Sides are comprised of a single
layer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 3M Medical
Adhesive Tape. |
| Intended Use | Exact Medical Manufacturing Surgical Drape Surgical Drape SMS 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 Surgical Drape SMS 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 Surgical Drape SMS 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 Surgical Drape SMS w/PE Sides is
substantially equivalent and meets the same acceptance criteria as the predicate
device/gown in K021864. Non-clinical performance testing includes: Biocompatibility
(cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier
properties AAMI PB:70 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. |
| 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 K021864
except for minor variations in the widths and lengths. |
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Image /page/1/Picture/0 description: The image shows a square divided into four equal quadrants. The top left quadrant is filled with a solid black color. The remaining three quadrants are filled with a pattern of dots. The dots are arranged in rows and columns, creating a grid-like pattern.
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:
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xact Medical Manufacturing, Inc.
K/01598
Addendum A
Summary and Explanation of Technological Characteristics: EMM SURGICAL DRAPE SMS w/PE Sides Predicate Device Comparison Table
| Exact Medical Manufacturing - Surgical Drape
SMS w/PE Sides
Model # 13-005 | Substantially
Equivalent | Primeline (Primagard) Surgical Drapes
510(k)021864
PREDICATE DEVICE |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: Exact Medical Manufacturing
Surgical Drape SMS 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. | Substantially
Equivalent | 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: SMS
(spunbond/meitblown/spunbond polypropylene),
Polyethylene, Absorbent Reinforcement, 3M
medical grade adhesive | Substantially
Equivalent | SMS, absorbent reinforcement, 3M medical grade
adhesive |
| 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. Hydrostatic Head
=/> 50 cm | Substantially
Equivalent | Hydrostatic head = 30.5 cm |
| Sterile (via EO Gas) ISO 11135-1:2007,
Sterilization of health care products - Ethylene
Oxide - Part 1 | Not Applicable | Non-sterile |
| Non-Sterile | Substantially
Equivalent | Non-sterile |
| Sterile Packaging: Chevron peel pouch (coated
paper (73gsm), PET12/PE40 film construction),
individual CSR internal wrap | Not Applicable | Not Applicable |
| Biocompatibility: cytotoxicity, irritation and
sensitization - ISO 10993-5:1999, Cytotoxicity,
ISO 10993-10:2002, Skin Irritation, ISO 10993-
10:2002, Sensitization.
Cytotoxicity, Irritation, Sensitization tests
PASS | Substantially
Equivalent | Cytotoxicity, Irritation, Sensitization PASS |
| Tear Strength - ASTM D5587-08 (no rev.)
Standard Test Method for Tearing Strength of
Fabrics by Trapezoid Procedure.
Tensile Strength for Md and Cd within general
industry tolerance +/- 20% | Substantially
Equivalent | Md=1.83 Ibs
Cd= 3.24 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 within general
industry tolerance +/- 20% | Substantially
Equivalent | Md=13.8 lbs
Cd=18.8 lbs |
| Flammability - 16CFR1610:2010, Flammability of
Clothing Textiles
Class 1 - PASS | Substantially
Equivalent | Class 1 |
| Lint and other Particles generated in the dry
state - ISO 9073-10:2003 | Not Applicable | No test |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol with three curved lines, resembling a human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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
OCT 4 2010
Re: K101598
Trade/Device Name: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides, Model 13-005 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape-and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 17, 2010 Received: September 24, 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.
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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,
h 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
Enclosure
4
Indications for Use Form
Indications for Use:
510(k) Number (if known): K101598
Device Name: Exact Medical Manufacturing Surgical Drape SMS w/PE Sides, Model 13-005
Indications for Use: Exact Medical Manufacturing Surgical Drape SMS 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 SMS w/PE Sides 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)
s Elizabeth F. Clarence-William
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthoolor of Infection Control, Devices
510(k) Number: K