(96 days)
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
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.
The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides, Model 13-004".
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|
| Water Resistance: Impact Penetration Test (AATCC 42:2007) | <1.0 gm Blotter water weight gain (Ref: AAMI PB70:2003/(R)2009, Level 3) | Pass |
| Water Resistance: Hydrostatic Pressure Test (AATCC 127:2008) | =/> 50 cm hydrostatic resistance (Ref: AAMI PB70:2003/(R)2009, Level 3) | Pass |
| Biocompatibility: In Vitro Cytotoxicity (ISO 10993-5:1999) | Evidence of cell lysis or toxicity < 2 | Pass |
| Biocompatibility: Skin Irritation (ISO 10993-10:2002) | No (0) edema or erythema observed | Pass |
| Biocompatibility: Skin Sensitization (ISO 10993-10:2002) | No evidence of causing delayed dermal contact sensitization | Pass |
| Flammability of Clothing Textiles (16CFR1610:2010) | Class 1 =/> 3.5 sec. average flame spread | Pass (Class 1) |
| Tearing Strength of Fabrics by Trapezoid Procedure (ASTM D5587-08) | Acceptance criteria not established in recognized standard. Exceeds predicate performance. | Pass |
| Breaking Strength and Elongation of Textile Fabrics (Grab Test) (ASTM D5034-09) | Acceptance criteria not established in recognized standard. Exceeds predicate performance. | Pass |
| Sterilization of health care products - Ethylene oxide (ISO 11135-1:2007) | SAL of > $10^{-6}$ | Pass |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008) | Average daily dose of EO/ECH shall not exceed 4mg/9mg | Pass |
| Lint and other particles generation in the dry state (ISO 9073-10:2003) | Acceptance criteria not established in the recognized standard. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the sample size for each test. However, for each test, a single "Finished Good Lot Number" (0980APA2) of the device (Model No. 13-004 Sterile) was used as the "Test Article". This suggests that samples from this specific lot were subjected to all listed tests.
- Data Provenance: The tests were conducted across several accredited laboratories:
- Nelson Labs, Utah, USA
- LexaMed, Ohio, USA
- LexaMed/NAMSA, Ohio, USA
- SCDC, Shanghai, CN
- GOALS Sterilization Co., Jiaxing, CN
The data appears to be prospective as it involves pre-market testing of the device against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this document. The tests performed are objective, physical, and chemical performance tests for a medical device (surgical drape), not diagnostic tests requiring expert interpretation of results or ground truth derived from expert consensus. The "ground truth" is established by the specified industry standards and their defined acceptance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, where multiple experts might disagree on an outcome. For these performance tests, the results either objectively meet or do not meet the predefined numerical or qualitative criteria of the standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a surgical drape, not an AI-powered diagnostic tool, and therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical drape, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests of the surgical drape is based on recognized industry standards and their predefined acceptance criteria. This includes standards like AATCC, ASTM, ISO, and 16CFR, which specify objective measurements and thresholds for properties such as water resistance, biocompatibility, flammability, and tensile strength.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in its evaluation.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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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, PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086dnowicki@exactmm.com(p)716-681-0866, (f) 716-681-4110 | |
| Primary Contact for this 510(k) Submission | David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086dnowicki@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 ClassificationName | 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 aresterile or non-sterile single use devices made of natural or synthetic materialsintended to be used as a protective patient covering, such as to isolate a siteof surgical incision from microbial and other contamination.Exact Medical Manufacturing Surgical Drapes-Spunlace w/PE Sides arecomprised of Spunlace, Polyethylene, 3M Medical Adhesive Tape. | |
| Intended Use | Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides aresterile or non-sterile single use devices made of natural or synthetic materialsintended to be used as a protective patient covering, such as to isolate a siteof surgical incision from microbial and other contaminationThe Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides arealso sold as bulk non-sterile, single use items, to repackager/relabelerestablishments for further packaging and ethylene oxide sterilization. | |
| Technological Characteristics | Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides has thesame design, material and performance characteristics of the predicatedevice. Additional Summary and Explanation of TechnologicalCharacteristics is included in the following Addendum A | |
| Summary of Testing | Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides aresubstantially equivalent and meet the same acceptance criteria as thepredicate device/gown in K964142 Non-clinical performance testingincludes:Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with themethods of ISO 10993, Barrier properties, Level 2, tensile, tear strength,flammability, linting and sterility. All results of the testing met acceptancecriteria. Additional Summary and explanation of non-clinical testing isincluded in the following Addendum B. | |
| Substantial Equivalence | The surgical drapes described in this 510(k) submission are substantiallyequivalent in all specifications and performance compared to the predicatedevice indentified in K964142 except for minor variations in the widths andlengths. | |
| Exact Medical Manufacturing - Surgical Drape-Spunlace w/PE SidesModel #13-004 | SubstantiallyEquivalent | PREDICATE DEVICEMedline (Proxima) Surgical Drapes510(k)964142 |
| Indications for Use: Exact Medical ManufacturingSurgical Drape -Spunlace w/PE Sides are sterile ornon-sterile single use devices made of natural orsynthetic materials intended to be used as a protectivepatient covering, such as to isolate a site of surgicalincision from microbial and other contaminationThe Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides are also sold as bulk non-sterile,single use items, to repackager/relabelerestablishments for further packaging and ethylene oxidesterilization. | SubstantiallyEquivalent | Indications for Use: devices made of naturalor synthetic materials intended to be used asa protective patient covering, such as toisolate a site of surgical incision frommicrobial and other contamination. |
| Classification & Code: KKX, Surgical Drapes,21CFR878.4370, Class II | SubstantiallyEquivalent | Classification & Code: KKX, SurgicalDrapes, 21CFR878.4370, Class II |
| Materials & Construction: Spunlace, Polyethylene,Absorbent Reinforcement, 3M Medical adhesive tape | SubstantiallyEquivalent | Materials & Construction: Spunlace,Absorbent reinforcement with imperviouspolyethylene backing, 3M Medical adhesivetape |
| Barrier properties - AATCC 42:2007, AATCC127:2008: Liquid Barrier Performance and Classificationof Protective Apparel and Drapes intended for Use inHealth Care Facilities, AAMI PB70:2003 /(R)2009,'el 2Electrostatic Head = 231 cm PASS | SubstantiallyEquivalent | Hydrostatic head = 19.5 cm |
| Sterile (via EO Gas) ISO 11135-1:2007, Sterilization ofhealth care products - Ethylene oxide - Part 1 | Not Applicable | |
| Sterile Packaging: Chevron peel pouch (coated paper(73gsm), PET12/PE40 film construction), individualCSR internal wrap | Not Applicable | Not Applicable |
| Non-sterile | SubstantiallyEquivalent | Non-sterile |
| Biocompatibility: cytotoxicity, irritation andsensitization - ISO 10993-5:1999, Cytotoxicity, ISO10993-10:2002, Skin Irritation, ISO 10993-10:2002,SensitizationCytotoxicity, Irritation, Sensitization test PASS | SubstantiallyEquivalent | Biocompatibility: Cytotoxicity, Irritation,Sensitization; PASS |
| Tear strength - ASTM D5587-08 (no rev.) StandardTest Method for Tearing Strength of Fabrics byTrapezoid ProcedureTear strength for Md and Cd exceeds predicateperformance | SubstantiallyEquivalent | Md = 2.5 lbsCd= 1.4 lbs |
| Tensile strength - ASTM D5034-09 (no rev.) StandardTest Method for Breaking Strength and Elongation ofTextile Fabrics (Grab Test)Tensile strength for Md and Cd exceeds predicateperformance | SubstantiallyEquivalent | Md = 23 lbsCd = 12.1 lbs |
| Flammability - 16CFR1610:2010, Flammability ofClothing TextilesClass 1 - PASS | SubstantiallyEquivalent | 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
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Addendum A Summary and Explanation of Technical Characteristics: EMM SURGICAL DRAPE Spunlace w/PE Sides Predicate Device Comparison Table
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Addendum B
Non-Clinical Testing Summary: EMM Surgical Drape – Spunlace w/PE Sides, Model # 13-004
| TestArticle | FinishedGood LotNumber | ReferenceStandard(s) | Description | Accept - RejectCriteria | Pass/Fail | Test Lab |
|---|---|---|---|---|---|---|
| ModelNo. 13-004Sterile | 0980APA2 | AATCC 42:2007(AAMI PB70:2003/(R)2009) | Water Resistance: ImpactPenetration Test, Level 3 | <1.0 gm Blotterwater weight gain | Pass | Nelson Labs,Utah, USA |
| ModelNo.13-004Sterile | 0980APA2 | AATCC 127:2008(AAMI PB70:2003/(R)2009) | Water Resistance: HydrostaticPressure Test, Level 3 | =/> 50 cmhydrostaticresistance | Pass | Nelson Labs,Utah, USA |
| ModelNo.13-004Sterile | 0980APA2 | ISO 10993-5:1999 | Biological evaluation of medicaldevices -- Part 5: Tests for invitro cytotoxicity | Evidence of cell lysisor toxicity < 2 | Pass | LexaMed, Ohio,USA |
| ModelNo.13-005Sterile | 0980APA2 | ISO 10993-10:2002 | Biological evaluation of medicaldevices -- Part 10: Tests forirritation and delayed-typehypersensitivity (Skin Irritation) | No (0) edema orerythema observed | Pass | LexaMed/NAMSA,Ohio, USA |
| ModelNo. 13-004Sterile | 0980APA2 | ISO 10993-10:2002 | Biological evaluation of medicaldevices - Part 10: Tests forirritation and delayed-typehypersensitivity (SkinSensitization) | No evidence ofcausing delayeddermal contactsensitization | Pass | LexaMed/NAMSA,Ohio, USA |
| ModelNo.13-004Sterile | 0980APA2 | 16CFR1610:2010 | Flammability of Clothing Textiles- Class 1 | Class 1 =/> 3.5 sec.average flamespread | Pass | Nelson Labs,Utah, USA |
| ModelNo. 13-004Sterile | 0980APA2 | ASTM D5587-08(no rev.) | Standard Test Method forTearing Strength of Fabrics byTrapezoid Procedure | Acceptance criterianot established inrecognizedstandard. Exceedspredicateperformance | Pass | Nelson Labs,Utah, USA |
| ModelNo.13-004Sterile | 0980APA2 | ASTM D5034-09(no rev.) | Standard Test Method forBreaking Strength andElongation of Textile Fabrics(Grab Test) | Acceptance criterianot established inrecognizedstandard. Exceedspredicateperformance | Pass | Nelson Labs,Utah, USA |
| ModelNo. 13-004 | 0980APA2 | ISO 11135-1:2007 | Sterilization of health careproducts - Ethylene oxide - Part1 | SAL of > $10^{-6}$ | Pass | SCDC, Shanghai,CN LexaMed,Ohio, USA |
| ModelNo. 13-004Sterile | 0980APA2 | ISO 10993-7:2008 | Biological Evaluation of MedicalDevices - Part 7: EthyleneOxide Sterilization Residuals | Average daily doseof EO/ECH shall notexceed 4mg/9mg | Pass | GOALSSterilization Co.Jiaxing, CN |
| ModelNo.13-004Sterile | 0980APA2 | ISO 9073-10:2003 | Lint and other particlesgeneration in the dry state | Acceptance criterianot established inthe recognizedstandard | Pass | Nelson Labs,Utah, USA |
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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.
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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,
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
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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:
§ 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.