(114 days)
The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during surgical procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination.
DEKA Medical, Inc., will market Surgical Drapes composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluid transfer across them, thus function to isolate the operative site from the surrounding area. Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The DEKA Medical Surgical Drapes will be subjected to a sterilizing dose of gamma radiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6.
The provided text describes a 510(k) submission for a Patient Drape product, not an AI-powered device. Therefore, a direct comparison using typical AI/ML acceptance criteria and study methodologies (like those that assess algorithm performance, MRMC studies, or multi-reader, multi-case studies) is not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (Invotec International, Inc. Ear Drape K911039) for a medical device (surgical drape) that is not an AI-driven product. The study described is a nonclinical test data analysis, primarily evaluating the physical properties and biocompatibility of the materials used in the drapes.
However, I can extract the relevant information about the acceptance criteria and the "study" (nonclinical testing) as presented in the document for the Patient Drape:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (from predicate or general standards) | Reported Device Performance (DEKA Surgical Drapes) |
|---|---|---|
| Indications for Use | Otological Procedures (Predicate device) | Otological, Ophthalmic, Heart & Neurological, OB/GYN, and Arthroscopic Procedures (Expanded from predicate) |
| Target Population | Otological Surgery candidates (Predicate device) | Candidates for Otological, Ophthalmic, Heart & Neurological, Peri/OB, and Arthroscopic Procedures (Expanded from predicate) |
| Design | Isolates ear surgical site from surrounding area through the use of barrier materials (Predicate device example) | Isolates ear, eye, chest, abdomen, pelvic, or extremities from surrounding area depending on drape through the use of barrier materials. Incorporates fluid collection attachments depending on drape. |
| Materials | Polyethylene film or nonwoven fabrics, adhesive tapes (Predicate device) | Nonwoven fabrics, Polyethylene film, adhesive tapes (Similar to predicate) |
| Performance | Impermeable to fluid transfer, sufficient tensile strength, puncture resistance, barrier integrity, and flammability classification (Implied from predicate/standards) | Data from suppliers indicate nonwoven fabric and various thicknesses of polyethylene film are impermeable to liquids for the duration of indicated procedures. Tensile strength and puncture resistance data indicate sufficient strength and resistance to maintain barrier integrity. Nonwoven fabric and foam laminate pass 16 CFR Part 1610 (Flammability Class 1 and 2). Polyethylene film flammability comparable to Invotec. |
| Sterility | Per ISO 11135 (Ethylene Oxide) (Predicate device) | Per ISO 11137 (Gamma irradiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6) (Different method, but assures sterility) |
| Biocompatibility | Skin contact only (Predicate device) | None irritating or sensitizing to ISO 10993-10 Standard. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. The performance data is derived from material supplier data and specific laboratory tests on the drape materials and a "Composite Patient Drape." The exact number of material samples or drapes tested is not specified.
- Data Provenance: The data is "Physical properties data obtained from suppliers of DEKA Medical Surgical Drape nonwoven fabric, polyethylene films, and skin contacting adhesives." It also includes "Biocompatibility testing... of a gamma sterilized Composite Patient Drape." This is primarily retrospective (data from suppliers) and prospective (specific biocompatibility testing). The country of origin is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for this medical device is based on objective physical and chemical properties testing against established standards (e.g., ISO for sterility and biocompatibility, 16 CFR for flammability), not expert interpretation of outputs.
4. Adjudication method for the test set
- Not applicable as the "test set" involves objective laboratory measurements against predefined specifications, not subjective reviewer performance.
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
- Not applicable. This is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is based on objective measurements and adherence to established industry standards and regulations for material properties and performance. Examples include:
- Material specifications confirming impermeability, tensile strength, and puncture resistance (from suppliers).
- Regulatory standards like 16 CFR Part 1610 for flammability.
- International Standards like ISO 11137 for sterility assurance and ISO 10993-10 for biocompatibility.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the inherent properties of the manufactured materials and products.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of medical device.
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MAY 1 5 1998
Image /page/0/Picture/1 description: The image contains a handwritten sequence of characters. The sequence starts with the letters 'K' and '9', followed by the number '8'. After that, there is a '0', then the number '210'. The characters are written in a dark ink on a white background.
510(k) SUMMARY
| Submitted by: | DEKA Medical, Inc.4820 Executive Park Court, Suite 110Jacksonville, FL 32216 |
|---|---|
| Telephone: | (904) 296-9977(904) 296-6508 (FAX) |
| Contact: | Donald G. White |
| Prepared: | 20 January 1998 (Original Submission)28 April 1998 (revised) |
| Proprietary Name: | Patient Drape |
| Common Name: | Surgical Drape or Patient Drape |
| Classification Name: | Drape, Surgical (21 CFR Part 878.4370) |
| Predicate Device: | Invotec International, Inc. Ear Drape(K911039) |
Device Description: DEKA Medical, Inc., will market Surgical Drapes composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluid transfer across them, thus function to isolate the operative site from the surrounding area. Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The DEKA Medical Surgical Drapes will be subjected to a sterilizing dose of gamma radiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6.
Intended Use: The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination. The target population for both the Invotec Ear Drape and the DEKA Medical Surgical Drapes is patients undergoing Otological procedures. In addition the DEKA Medical Surgical
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Drapes are intended for patients undergoing Ophthalmic, Heart & Neurological. Peri/OB. Arthroscopic, and Specialty Procedures. Substantial equivalence is evidenced by the fact that both the Invotec Ear Drape and the DEKA Medical Surgical Drapes are constructed of nonwoven fabric or polyethylene film. Data provided by suppliers of these materials for the DEKA Medical Surgical Drapes indicate they are impermeable to fluids and are compatible for skin contact applications.
The primary difference between the Invotec Ear Drape and the DEKA Medical Surgical Drapes is the method of sterilization. The Invotec Ear Drape is Ethylene Oxide sterilized whereas the DEKA Medical Surgical Drapes are gamma irradiation sterilized. However, sterility is assured by either method and the DEKA Medical Surgical drapes have been found to be biocompatible following gamma irradiation.
Technological Comparison: A comparison of the technological characteristics of the DEKA Medical, Inc., surgical drape and the Invotec ear drape is indicated in the table below:
| Characteristic | Invotec Ear Drape | DEKA Surgical Drapes |
|---|---|---|
| Indications for use | Otological Procedures | Otological, Ophthalmic,Heart & Neurological,OB/GYN, andArthroscopic Procedures |
| Target Population | Otological Surgerycandidates | Candidates forOtological, Opthalmic,Heart & Neurological,Peri/OB, andArthroscopic Procedures |
| Design | Isolates ear surgical sitefrom surrounding areathrough the use ofbarrier materials | Isolates ear, eye, chest,abdomen, pelvic, orextremities fromsurrounding areadepending on drapethrough the use ofbarrier materials.Incorporates fluidcollection attachmentsdepending on drape. |
| Materials | Polyethylene film ornonwoven fabrics | Nonwoven fabrics,Polyethylene film, |
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| Characteristic | Invotec Ear Drape | DEKA Surgical Drapes |
|---|---|---|
| adhesive tapes | adhesive tapes | |
| Performance | See adjoining table | See adjoining table |
| Sterility | Per ISO 11135 | Per ISO 11137 |
| Biocompatibility | Skin contact only | None irritating orsensitizing to ISO10993-10 Standard |
Nonclinical Test Data
Physical properties data was obtained from suppliers of DEKA Medical Surgical Drape nonwoven fabric, polyethylene films, and skin contacting adhesives. These data show the Dexter nonwoven fabric and the various thickness of polyethylene film are impermeable to liquids for the duration of the indicated procedures (see Table below). Tensile strength and puncture resistance data indicate these materials have sufficient tensile strength and puncture resistance to maintain barrier integrity during indicated procedures. The DEKA Medical nonwoven fabric and foam laminate pass the 16 CFR Part 1610 Flammability Classification (Flammability Class 1 and 2). No Classification data is available on DEKA Medical Surqical Drape polyethylene film. However, the flammability of various polyethylene films is comparable and would not be substantially different in flammability from the Invotec Ear Drape polyethylene film. Biocompatibility testing in conformance to ISO 10993-10 of a gamma sterilized Composite Patient Drape shows the drapes to be nonirritating and nonsensitizing.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald G. White ·Director QA/RA Deka™ Medical, Incorporated 4820 Executive Park Court, Suite 110 Jacksonbville, Florida 32216
Re : K980210 Trade Name: Various Surqical or Patient Drapes Requlatory Class: II Product Code: KKX Dated: April 29, 1998 Received: April 30, 1998
Dear Mr. White:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. White
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K980210 Device Name: Various Surgical OR Patrent Drape
STATEMENT OF INDICATIONS FOR USE
The various surgical or patient drapes manufactured by DEKA Medical, Inc.,
The various surgical controllerister in interested to used as a protective The Vanous surgical or patient urapos naterials intended to be used as a protective
consist of natural or synthetic materials intended to be used of the dra consist of natural or synthelic intenstals intended to to arous of the drapes
patient covering during surgical procedures. The primary purpose of the drapes patient covering during surgical procedures: " The philiasy for ther contamination.
is to isolate a site of surgical incision from microbial or other contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ohm S. Lin
(Division Sign-Off) Division of Dental, Info and General Hosp 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 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.