(223 days)
Not Found
No
The device description and intended use clearly define the product as a sterile cover/drape kit for ultrasound transducers, acting as a physical barrier. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance study mentioned (ASTM - F1671-95) is a standard test method for resistance of materials to penetration by blood-borne pathogens, consistent with the device's function as a barrier.
No
The device is described as a sterile cover/drape kit for an ultrasound transducer, acting as a barrier and accessory to the ultrasound instrument. Its primary function is to provide a sterile covering, not to directly treat or diagnose a medical condition.
No.
The device is described as a sterile cover/drape kit for an ultrasound transducer, acting as a barrier between the patient and the probe. Its function is to provide a sterile field and protection, not to diagnose medical conditions.
No
The device description clearly states it is a physical kit containing a polyethylene cover/drape, gel, bands, and tape, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a sterile cover/drape kit used as an accessory to an ultrasound transducer. Its primary function is to act as a sterile barrier between the non-sterile ultrasound probe and the patient's body (internal and external surfaces) during ultrasound procedures.
- Intended Use: The intended uses listed (general ultrasound scanning, cord cover, rectal/vaginal scanning, surgical site isolation) all involve the device being used on or in contact with the patient's body during an imaging procedure. It does not involve the analysis of specimens taken from the body.
- Device Description: The description confirms it's a physical barrier placed over the ultrasound probe.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, chemical reactions, or any other activities typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used in conjunction with an imaging modality (ultrasound) for diagnostic or procedural purposes, but it is not an IVD.
N/A
Intended Use / Indications for 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.
Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
human bodies internal and external services, Where Ultrasound is Used
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Sonographers, Doctor's and Technicians. Hospitals & Clinics
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)
Performance: ASTM - F1671-95
Sterility: ETO
Biocompatibility: ISO-10993
Mechanical Safety: Tensile Strength 2400 - 3500 PSI
Chemical Safety: No Hazardous Components 29CFR 1910,1200
Electrical Safety: No Electrical Components
Human Factor: No Known Adverse Effects
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.
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
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
1
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.
2
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)
3
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's | |
| and Technicians | Sonographers, Doctor's | |
| and Technicians | ||
| Design | Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials | Polyethylene .001-.003inches | Polyethylene .001-.003inches |
| Additional Kit | ||
| Components | Conductivity Gel | |
| Elastic Bands | ||
| Plastic Medical Tape | Conductivity Gel | |
| Elastic Bands | ||
| Performance | ASTM - F1671-95 | ASTM - F1671-95 |
| Sterility | ETO | ETO |
| Biocompatibility | 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 |
| Standards Met | Global Test Methods for | |
| Resistance to Penetration | Global Test Methods for | |
| Resistance to Penetration | ||
| Electrical Safety | No Electrical Components | No Electrical Components |
| 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 |
PROTEK Medical Products Inc. Contact: Rick L. Protect Phone (319)358-8080 Fax (319)339-3258
4
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.
5
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
6
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
7
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