(164 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a surgical drape, with no mention of AI/ML, image processing, or data-driven performance metrics.
No
The device is described as a surgical drape/cover for an ultrasound transducer probe, designed to create a sterile barrier and prevent cross-contamination. It does not directly treat a disease or condition.
No
The device is described as a sterile bag or drape used to cover a non-sterile ultrasound transducer, acting as a barrier to prevent cross-contamination. Its primary function is protective and not to diagnose.
No
The device description clearly states it is a sterile bag/drape, which is a physical, hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a "protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants." This is a barrier function for infection control during a surgical procedure.
- Device Description: The description reinforces this by stating it's a "sterile bag to contain a non-sterile ultrasound transducer probe" and a "sterile barrier between patient and ultrasound transducer probe."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze these specimens. This device is used in vivo (on the body) as a physical barrier.
The device is a sterile medical device used for infection control during ultrasound procedures, not an IVD.
N/A
Intended Use / Indications for Use
A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure.
A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria's of a non-sterile ultrasound transducer probe. A sterile barrier between patient and ultrasound transducer probe.
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.
K895614, K844472, K943393, K882724
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve and resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2004
Mr. Rick L. Pruter PROTEK Medical Products, Incorporated 221 East Market Street, Suite 291 Iowa City, Iowa 52245-2166
Re: K970891
Trade/Device Name: Latex Ultrasound Transducer Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 12, 1997 Received: July 23, 1997
Dear Mr. Pruter:
This letter corrects our substantially equivalent letter of August 22, 1997 regarding the product code.
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 lecally 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 (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.
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. Pruter
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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PRODUCTS INC. 211 E MARKET SUITE 291 10WA CITY 13 319-358 8080 FAX 319 339 8258 USA 52245-2166
155 22 1551
February 20, 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 LATEX ULTRASOUND TRANSDUCER SURGICAL DRAPE
SUBMITTER: Rick L. Pruter COMPANY: PROTEK Medical Products Inc. 221 East Market Street ADDRESS: CITY: Iowa City Iowa STATE: COUNTRY: USA CONTACT: Rick L. Pruter PHONE: (319)358-8080 FAX: (319)339-8258 DATE SUMMARY PREPARED: January 21, 1997 ULTRASOUND TRANSDUCER DRAPE-LATEX TRADE NAME: COMMON NAME: TRANSDUCER COVER, PROBE COVER, SURGICAL DRAPE, INSTRUMENT COVER SURGICAL DRAPE (per 21 CFR Section 878.4370) CLASSIFICATION NAME:
3
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:
| New Device
| PROTEK Medical Products Inc. | Predicate Device | ||
|---|---|---|---|
| Civco's | Civco's 510(k) | ||
| 1-519-0350 | 5 X 30 | 610-043 | K895614 |
| 1-519-0380 | 8 X 30 | 610-044 | K895614 |
| 1-519-0399 | 10 X 30 | 610-046 | K895614 |
| 1-519-0320 | 2 X 20 | 610-075 | K895614 |
| 1-519-0326 | 2.6 X 20 | 610-213 | K895614 |
| 1-519-0335 | 3.5 X 20 | 610-214 | K895614 |
| 1-519-0336 | 3.5 X 20 | 610-010 | K895614 |
The following is a cross reference of products that will be identical:
*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 people that tested and processed Civco's legally marketed devices. Other 510(k) numbers that have the same intended use are K844472 and K943393 under Civco Medical, K882724 MicroTek Probe Drape and 3m #1071 Drape
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4
SUMMARY
DEVICE DESCRIPTION:
Narrative Description:
A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure.
A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria's of a non-sterile ultrasound transducer probe. A sterile barrier between patient and ultrasound transducer probe.
Device Physical Specifications:
Dip molded natural latex rubber Thickness-. 001-. 007 Sizes-Sizes range from 1.5cm X 10cm thru 8.0cm x 30cm
Intended use:
A cover/drape or sterile barrier placed on an ultrasound transducer 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.
-
- Intro-operative procedure that use non-sterile ultrasound transducers and require an extra sterile barrier. This would include invasive procedures where blood path indirect contact may occur.
-
- Rectal and vaginal scanning.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:
(SEE ATTACHED CHART - APPENDIX D)
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Appendix D in SUMMARY
Substantially Equivalence Comparison Chart With Civco Medical
| Description
| Comment | 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 | LATEX.001-.007 | LATEX .001-.007 |
| Vendors | Kent Latex, Ohio | |
| Killian Latex, Ohio | Kent Latex. Ohio | |
| Killian Latex, Ohio | ||
| Performance | ASTM - ES - 22 | ASTM - ES - 22 |
| 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 | ||
| Manufacturing | ||
| Method | Dipped Latex | Vertrod Heat Scaler |
| Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor | Labels identify this product as | |
| Latex | Labels identify this product as | |
| Latex |
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K970891 510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name:
Indication for Use:
Latex Drapes for Ultrasound Transducers.
A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE TO ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital, Intection
and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over The Counter Use X
(Optional Format 1-2-96)