(223 days)
A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses:
- General Purpose: Ultrasound scanning
- Cord cover for an extended sterile field on ultrasound transducer cords.
- Rectal and vaginal scanning.
- Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.
Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.
A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.
Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyethylene film, with a thickness of .001inches-.003inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
The provided document describes a 510(k) premarket notification for a Polyethylene Ultrasound Transducer Surgical Drape Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data as would be found for novel technologies or higher-risk devices.
Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types beyond basic material testing) are not applicable in the context of this 510(k) submission for a surgical drape kit. The primary 'study' is a comparison to a predicate device and adherence to recognized standards.
Here's a breakdown of the information that is available in the provided text, mapped to your request:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by showing substantial equivalence to the predicate device (Civco Medical K844472) and adherence to industry standards for materials and performance. The 'reported device performance' is therefore its equivalence to the predicate and its compliance with specified standards.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (PROTEX Medical Products Inc.) |
|---|---|
| Indications for use: Ultrasound transducer covers | Ultrasound transducer covers |
| Target Population: Sonographers, Doctors, Technicians | Sonographers, Doctors, Technicians |
| Design: Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials: Polyethylene .001-.003 inches | Polyethylene .001-.003 inches |
| Additional Kit Components: Conductivity Gel, Elastic Bands | Conductivity Gel, Elastic Bands, Plastic Medical Tape |
| Performance Standard: ASTM - F1671-95 (Resistance to Penetration) | ASTM - F1671-95 |
| Sterility: ETO | ETO |
| Biocompatibility Standard: ISO-10993 | ISO-10993 |
| Mechanical Safety (Tensile Strength): 2400-3500 PSI | Tensile Strength: 2400-3500 PSI |
| Chemical Safety: No Hazardous Components (29CFR 1910,1200) | No Hazardous Components (29CFR 1910,1200) |
| Anatomical Sites: Where Ultrasound is Used | Where Ultrasound is Used |
| Disposition: Disposable | Disposable |
| Where Used: Hospitals & Clinics | Hospitals & Clinics |
| Manufacturing Method: Vertrod Heat Sealer | Vertrod Heat Sealer |
| Packaging: TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor: No Known Adverse Effects | No Known Adverse Effects |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable (N/A) for a 510(k) of this nature. This submission demonstrates substantial equivalence through material and performance specifications rather than a clinical trial-like test set. The 'test' involves demonstrating the device meets specified material and performance standards (e.g., ASTM F1671-95 for resistance to penetration, ISO-10993 for biocompatibility, tensile strength). The data provenance refers to the standards themselves and internal testing results, not patient data.
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)
N/A. The "ground truth" here is compliance with established engineering and safety standards, and the specifications of the predicate device. This doesn't involve expert medical review of images or clinical outcomes in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. The assessment is against material properties and performance specifications, not subjective clinical adjudication.
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
N/A. This is a medical device (surgical drape), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is based on:
- Material specifications: Polyethylene thickness, properties.
- Performance standards: Adherence to ASTM F1671-95 (standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system).
- Safety standards: ISO-10993 (biological evaluation of medical devices), 29CFR 1910,1200 (hazard communication standard for chemical safety).
- Predicate device characteristics: Demonstrating that the new device has the same design, materials, performance, sterility, etc., as the legally marketed Civco Medical device (K844472).
8. The sample size for the training set
N/A. As this is a physical medical device applying for 510(k) equivalence, there is no AI model or "training set" in the computational sense. The 'training' would refer to the historical data and manufacturing processes that led to the development and standardization of such surgical drapes, but this is not specified in the document.
9. How the ground truth for the training set was established
N/A. See point 8.
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Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylenc Surgical Drape Kit K970889
6-1
OCT 20 1997
E MARKET SUITE 291 10WA CITY 14 319-368-8080 FAX 319-339-8258 USA 52245-2166
October 17, 1997
Document Mail Center Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA
SUMMARY PREMARKET NOTIFICATION 510 (k) FOR POLYETHYLENE ULTRASOUND TRANSDUCER
SURGICAL DRAPE KIT
| SUBMITTER: | Rick L. Pruter |
|---|---|
| COMPANY: | PROTEK Medical Products Inc. |
| ADDRESS: | 221 East Market Street |
| CITY: | Iowa City |
| STATE: | Iowa |
| COUNTRY: | USA |
| CONTACT: | Rick L. Pruter |
| PHONE: | (319)358-8080 |
| FAX: | (319)339-8258 |
| DATE SUMMARY PREPARED: | January 21, 1997 |
| TRADE NAME: | ULTRASOUND TRANSDUCER DRAPE KIT -POLYETHYLENE |
| COMMON NAME: | TRANSDUCER COVER, PROBE COVER,SURGICAL DRAPE, INSTRUMENT COVER |
| CLASSIFICATION NAME: | SURGICAL DRAPE (per 21 CFR Section 878.4376) |
PROTEK Medical Products Inc. Custost: Rick L. Prutar Phone (3) 9)358-8080 Fax (319)339-$258
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Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit KS710889
6-2
SUMMARY
COMMERCIALLY PRODUCED PRODUCTS OF EQUIVALENCE:
There are several products of equivalence legally marketed including the following: Amedic of Sweden, MicroTek of Mississippi, USA and Civco Medical from Iowa, USA.
These devices are similar to the predicate devices in respect to the materials, packaging, distribution and intended use.
Substantial Equivalence Comparison:
The following is a cross reference of products that will be identical:
| New Device | Predicate Device | Civco's 510(k) |
|---|---|---|
| PROTEK Medical Inc. | Civco | |
| 1-519-0122 | 610-013 | K844472 |
| 1-519-0124 | 610-015 | K844472 |
| 1-519-0126 | 610-209 | K844472 |
*Other part numbers vary only on size and shape
These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures the same tests and processes as Civco's legally marketed devices under 510(k) K844472.
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Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit KS910889
SUMMARY
ર-૩
DEVICE DESCRIPTION:
Narrative Description:
A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.
Device Physical Specifications:
Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyethylene film, with a thickness of . 00 linches-. 003inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
Intended use:
A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses:
-
- General Purpose: Ultrasound scanning
-
- Cord cover for an extended sterile field on ultrasound transducer cords.
-
- Rectal and vaginal scanning.
-
- Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:
(SEE ATTACHED CHART - APPENDIX D)
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6-4
Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit KS70089
Appendix D in SUMMARY
Substantially Equivalence Comparison Chart With Civco Medical K844472
| Description | PROTEK Medical Products Inc. | Civco Medical |
|---|---|---|
| Indications for use | Ultrasound transducer covers | Ultrasound transducer covers |
| Target Population | Sonographers, Doctor'sand Technicians | Sonographers, Doctor'sand Technicians |
| Design | Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials | Polyethylene .001-.003inches | Polyethylene .001-.003inches |
| Additional KitComponents | Conductivity GelElastic BandsPlastic Medical Tape | Conductivity GelElastic Bands |
| Performance | ASTM - F1671-95 | ASTM - F1671-95 |
| Sterility | ETO | ETO |
| Biocompatibility | ISO-10993 | ISO-10993 |
| Mechanical Safety | Tensile Strength2400 - 3500 PSI | Tensile Strength2400 - 3500 PSI |
| Chemical Safety | No Hazardous Components29CFR 1910,1200 | No Hazardous Components29CFR 1910,1200 |
| Anatomical Sites | Where Ultrasound is Used | Where Ultrasound is Used |
| Disposition | Disposable | Disposable |
| Where Used | Hospitals & Clinics | Hospitals & Clinics |
| Standards Met | Global Test Methods forResistance to Penetration | Global Test Methods forResistance to Penetration |
| Electrical Safety | No Electrical Components | No Electrical Components |
| ManufacturingMethod | Vertrod Heat Sealer | Vertrod Heat Sealer |
| Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor | No Known Adverse Effects | No Known Adverse Effects |
PROTEK Medical Products Inc. Contact: Rick L. Protect Phone (319)358-8080 Fax (319)339-3258
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.
OCT 20 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Rick L. Pruter President / CEO PROTEK Medical Products Incorporated 221 E. Market Street, Suite 291 Iowa City, Iowa 52245
Re: K970889 Ultrasound Transducer Drape Kits, Trade Name: Polyurethane Requlatory Class: II Product Code: KKX July 1, 1997 Dated: Received: July 23, 1997
Dear Mr. Pruter:
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 to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If vou purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.
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Page 2 - Mr. Pruter
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains Ultra/Phonic Conductivity Gel which are subject to regulation as drug.
Our substantially equivalent determination does not apply to the drug component [s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component [s]. For information on applicable Agency requirements for marketing this [these] drug[s], we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Druq Evaluation and Research Food and Druq Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding 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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the
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Page 3 - Mr. Pruter
Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 "dsmo@fdadr.cdrh.fda.gov"
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
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Document # 9-926-0001 Rev. 2 FDA 510(k) Notification-Polyethylene Surgical Drape
4-3
510(k) Number K970889
Statement Indication For Use
Device Name: Polyethylene Ultrasound Transducer Drape: Kirt
I, Rick L. Pruter, President/CEO of PROTEK Medical Products Inc., certify that the devices in this notification are used for:
Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.
Rick L. Pruter, President/CEO PROTEK Medical Products Inc.
Lucy 16, 97
Date
Chun 3. Gu
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Device 510(k) Number
PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258
§ 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.