(223 days)
Not Found
No
The device is 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.
No
The device is described as a sterile cover/drape kit for an ultrasound transducer, acting as a barrier between the instrument and the patient. Its function is to provide a sterile field and prevent contamination, not to diagnose, treat, or prevent disease, which are characteristics of a therapeutic device. It is an accessory to a diagnostic imaging tool.
No
Explanation: The device is described as a sterile cover/drape kit for ultrasound transducers, acting as a barrier between the patient and the probe. Its function is to provide infection control and maintain a sterile field, not to capture, process, or analyze medical data for diagnostic purposes.
No
The device is a physical kit containing a polyurethane 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 Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is a sterile cover/drape kit used as a barrier on an ultrasound transducer. Its primary function is to prevent contamination and maintain a sterile field during ultrasound procedures. It does not analyze or interact with specimens taken from the human body.
- Intended Use: The intended uses listed (general ultrasound scanning, cord cover, rectal/vaginal scanning, protective covering for surgical sites) all relate to the physical application of the ultrasound transducer to the patient, not the analysis of biological samples.
The device is an accessory to an ultrasound transducer, which is a medical imaging device. While ultrasound is used in diagnosis, the cover/drape itself is a physical barrier and not involved in the diagnostic process of analyzing biological samples.
N/A
Intended Use / Indications for Use
A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it 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 Polyurethane film, with a thickness of .001-. 003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
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
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Oct. 17 1997 12:51PM P1
Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kk IK970093
OCT 20 1997
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Image /page/0/Picture/5 description: The image shows the logo for Protek Medical Products Inc. The logo includes the company name, address, phone number, fax number, and zip code. The address is 211 E. Market Suite 291 Iowa City LA, the phone number is 319-358-8080, the fax number is 319-339-8256, and the zip code is 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 POLYURETHANE 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 - POLYURETHANE |
| COMMON NAME: | TRANSDUCER COVER, PROBE COVER, SURGICAL DRAPE, INSTRUMENT COVER |
| CLASSIFICATION NAME: | SURGICAL DRAPE (per 21 CFR Section 878.4370) |
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Document #9-926-0002 Rev. 4 FDA 510 (k) Natification-Polyurethane Surgical Drape Kit KS700893
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, (details in body of this submission appendix).
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 | ||
|---|---|---|
| PROTEK Medical Products Inc. | Civco | Civco's 5100K) |
| 1-519-0223 | 610-001 | K844472 |
| 1-519-0227 | 610-004 | K844472 |
| 1-519-0229 | 610-005 | K844472 |
| *Other part numbers vary only on size and shape |
- 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 and the same tests and processes as Civco's legally marketed devices under 510(k) K844472.
2
Document #9-926-0002, Rov. 4 FDA 510 (k) Notification-Polyunzhane Surgical Drape Kit K970893
SUMMARY
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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 Polyurethane film, with a thickness of .001-. 003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
Intended use:
A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it 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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Document #9-926-0002 Rov. 4 FDA 510 (k) Natification-Polyurethane Surgical Drape Kit IKST0893
Appendix D in SUMMARY
Substantially Equivalence Comparison Chart With Civco Medical K844472
| Description | PROTEK Medical Products Inc. | Civco Medical |
|---|---|---|
| Comment | ||
| 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 | Polyurethane .001"-.003" | Polyurethane .001"-.003" |
| Additional Kit | ||
| Components | Conductivity Gel | |
| Elastic Bands | ||
| Plastic Medical Tape | Conductivity Gel | |
| Elastic Bands | ||
| Performance | Microbial Challenge | Microbial Challenge |
| Sterility | ETO | ETO |
| Biocompatibility | ISO-10993 | ISO-10993 |
| Mechanical Safety | Tensile Strength | |
| 6250 PSI @ Break | Tensile Strength | |
| 6250 PSI @ Break | ||
| 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. Proter Phone (319)358-8080 Fax (319)339-8258
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 20 1997
Mr. Rick L. Pruter President/CEO PROTEK Medical Products Incorporated 221 E. Market Street, Suite 291 Iowa City, Iowa 52245
Re: K970893 Ultrasound Transducer Drape Kits, Trade Name: Polyurethane Requlatory Class: II Product Code: KKX Dated: June 30, 1997 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 of Act. However, you are responsible to determine that the 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 you 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 aqainst 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) requlation (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 Druq 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 leqally 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 requlation entitled, "Misbranding by reference to premarket regation" (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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
7
4-3
510(k) Number K970893
Statement Indication For Use
Device Name: Polyurethane Ultrasound Transducer Drape Kit
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.
7-18-97
Date
Clain S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258