(227 days)
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
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.
The provided document K121919 describes a surgical drape, not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML devices (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable.
However, I can extract the acceptance criteria and performance data for this physical medical device based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Predicate Device K102666) | Reported Device Performance (Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV) |
|---|---|---|
| Barrier Performance | AAMI PB70: Level 4 | AAMI PB70: Level 4 |
| Biocompatibility | Cytotoxicity, Primary Skin Irritation, Sensitization tests | ISO 10993-5:2009 Cytotoxicity, ISO 10993-10:2002 Skin Irritation, ISO 10993-10:2002 Sensitization |
| Tear Strength (ASTM 5587-08) | Unknown/Equivalent to Predicate | 19.4 lbs & 9.7 lbs |
| Breaking Strength (ASTM D5034-09) | Unknown/Equivalent to Predicate | 24.4 lbs & 15.9 lbs |
| Flammability (16CFR1610:2007) | Class 1 | Class 1 |
| Linting (ISO 9073-10:2003) | Unknown/Equivalent to Predicate | Reported as 'Substantially Equivalent' to predicate, implying it met predicate's (unknown) criteria |
| Sterility | Sterile via EO Gas | Sterile (via EO Gas) ISO 11135-1:2007 |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a "Summary of Testing" described in the 510(k) submission. It states:
"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."
Regarding AI/ML Specific Information (Categories 2-9):
As this is a physical surgical drape, the following categories are not applicable and no information is provided in the document:
- Sample size used for the test set and the data provenance: Not applicable for a physical device undergoing non-clinical performance testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties and performance are measured against standards, not expert consensus.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" or reference for acceptance is established by recognized international and national standards (e.g., AAMI PB70, ISO 10993, ASTM, 16CFR1610).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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 AAMILiquid Barrier Level IV | SubstantiallyEquivalent | Kimberly Clark CorporationSurgical Drapes with AAMI Liquid Barrier Level 4 claim510(k)102666PREDICATE DEVICE |
|---|---|---|---|---|
| June 26, 2012 | Intended Use: Exact Medical Manufacturing Surgical DrapeAAMI Level 4 are sterile or non-sterile single use devicesmade of natural or synthetic materials intended to be used asa protective patient covering, such as to isolate a site ofsurgical incision from microbial and other contamination. TheEMM Surgical Drapes AAMI Level 4 are also sold as bulknon-sterile, single use items, to repackager/relabelerestablishments for further packaging and ethylene oxidesterilization according to ISO 11135-1:2007. | SubstantiallyEquivalent | Intended Use: The Kimberly-Clark* Surgical Drapes with AAMILiquid Barrier Level 4 claim are devices made of natural orsynthetic material intended to be used as a protective patientcovering, such as to isolate a site of surgical incision frommicrobial and other contamination. These drapes meet the Level4 requirements of the AAM! Liquid Barrier Classifications. TheKimberly-Clark" Surgical Drapes with AAMI Liquid Barrier Level4 claim are also sold as bulk non-sterite, single use items, torepackager/relabeler establishments for further packaging andEthylene Oxide (EtO) sterilization. | |
| 510(k) Submitter | David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086dnowicki@exactmm.com(p)716-681-0866, (f) 716-681-4110FEB 14 2013 | Classification & Code: Surgical Drapes and DrapeAccessories, KKX, 21CFR878.4370, Class II | SubstantiallyEquivalent | Classification & Code: Surgical Drapes and Drape Accessories,KKX, 21CFR878.4370, Class II |
| 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 | Single Use - Disposable | SubstantiallyEquivalent | 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 inProtective Clothing to Penetration by Synthetic Blood | SubstantiallyEquivalent | Barrier Performance: AAMI PB70: Level 4 |
| Trade Name | Surgical Drape with AAMI Liquid Barrier Level IV | Materials & Construction: The base sheet fabric is a threelayer composite comprised of polypropylene spunbond and aco-extruded PE film. Layers are thermally bonded togetherproducing a single layer with various basis weights. The outerlayers are non-woven fabric, the inner layer is AAMI PB:70Level 4 capable PE film. | Materials & Construction:The base sheet fabric is a three layer laminatecomprised of polypropylene spunbond / polypropylenemeltblown/polypropylene spunbond. Layers are thermallyembossed together producing a single layer with varlous basisweights. Fabric is topically treated to enhance water repellencyand to assure static dissipation. | |
| Device Product Codes andClassification Name | KKX, 21CFR878.4370, Surgical Drape and Drape Accessories | Materials Weight per square meterWeight/m2PNRef.Description112005196-9611196cm/PMC04/Blue SMS43221340809797cm/PMC02 BiLam Mtl453213408152152cm/ BiLam Mtl454210401148-900 PSB3030 Pad804PE25 | SubstantiallyEquivalent | Unknown |
| Predicate Device | Kimberly Clark Corporation Surgical Drapes with AAMI Liquid Barrier Level 4 claim - K102666 | Color: BlueDye: Blue Colorant B373 (FB 1007) | Color: BlueDye: Unknown | |
| Device Description | Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devicesmade of natural or synthetic materials intended to be used as a protective patient covering, such as toisolate 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 athree layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers arethermally bonded together producing a single layer with various basis weights. The outer layers are nonwoven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film. | Sterile (via EO Gas) ISO 11135-1:2007, Sterilization of healthcare products - Ethylene oxide - Part 1 | SubstantiallyEquivalent | Sterile via EO Gas |
| Intended Use | Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devicesmade of natural or synthetic materials intended to be used as a protective patient covering, such as toisolate a site of surgical incision from microbial and other contamination. The EMM Surgical Drapes AAMILevel 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments forfurther packaging and ethylene oxide sterilization according to ISO 11135-1:2007 | Sterile Packaging: Chevron peel pouch (coated paper(73gsm), PET12/PE40 film construction), individual CSRInternal wrap | SubstantiallyEquivalent | 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) | SubstantiallyEquivalent | Non-sterile built pack |
| Summary of Testing | Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalentand meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinicalperformance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with themethods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, lintingand sterility. All results of the testing met acceptance criteria. | Biocompatibility: ISO 10993-5:2009 Cytotoxicity, ISO10993-10:2002, Skin Irritation, ISO 10993-10:2002,Sensitization | SubstantiallyEquivalent | tested for biocompatibility using cytotoxicity, primary skin irritationtests and sensitization testing. |
| Substantial Equivalence | The surgical Drapes described in this 510(k) submission are substantially equivalent in all specificationsand performance compared to the predicate device indentified in K102666. | Tear strength - ASTM 5587-08 (no rev.) Standard TestMethod for Tearing Strength of Fabrics by TrapezoidProcedure19.4 lbs & 9.7 lbs | SubstantiallyEquivalent | Tear strength - Unknown |
| Breaking strength - ASTM D5034-09 (no rev.) Standard TestMethod for Breaking Strength and Elongation of TextileFabrics (Grab Test)24.4 lbs & 15.9 lbs | SubstantiallyEquivalent | Breaking strength - unknown | ||
| Flammability - 16CFR1610:2007, Flammability of ClothingTextiles - Class 1 | SubstantiallyEquivalent | Class 1 | ||
| Linting - ISO 9073-10:2003, Lint and other particlesgenerated in the dry state | SubstantiallyEquivalent | Linting - Unknown |
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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.
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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.
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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 (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
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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 | |
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| 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 |
§ 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.