(81 days)
K-895614, K-943393, K-961029, K-953673, K-900805, K-920374
Not Found
No
The device description and intended use clearly define a physical sheath for ultrasound probes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended to facilitate cleaning and sanitization of ultrasound probes, not to directly treat a medical condition or restore health. While it's used in a medical setting, its function is for hygiene and protection of the probe, not for therapeutic purposes on a patient.
No
The device is described as a latex sheath placed on ultrasound probes to facilitate cleaning and sanitization, similar to condoms for this purpose. Its function is to cover the probe, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical latex sheath, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the cleaning and sanitization of ultrasound probes used in natural body orifices. This is a physical barrier function, not a diagnostic one.
- Device Description: The device is described as a latex sheath, similar to a condom, with varying dimensions. This description aligns with a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect biomarkers, or provide any information about a patient's health status or disease.
- Performance Studies: The performance studies mentioned focus on physical characteristics and biocompatibility, which are relevant to a barrier device, not a diagnostic one.
- Predicate Devices: The predicate devices listed are also described as "sheaths" or "probe covers," further indicating their function as physical barriers for hygiene purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.
- These products have the same intended use, to aid in avoiding contamination of ultrasonic probes by bodily fluids to facilitate cleaning of these probes. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.
Product codes (comma separated list FDA assigned to the subject device)
IYO, 90 ITX
Device Description
These devices are latex sheaths, closely related to condoms which have been used in the past for this purpose. However, these sheaths have different dimensions, depending on which probe they are designed to be used. They may range in size from about 30 cm. length, and 10 cm. in diameter to 6 cm. in length to 2 cm. in diameter with the 20 cm x 5 cm being the most common.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural body orifices--such as the vagina--
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Data used in determining substantial equivalence include those required by ASTM D3578-95, and biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary of Test Data Used in Determining Equivalence: Physical characteristics, before and after aging, Biocompatibility characteristics.
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.
K-895614, K-943393, K-961029, K-953673, K-900805, K-920374
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
6 1998 FEB
XI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. [Separate Page]
I. Submitter: George Kuo, CLK International, Inc., 28 East Broadway, New York, NY 10002 Ph: 212-334-3953
II. Classification Names and numbers: Accessory to Ultrasonic Imaging System, IYO, Class II.
III. Common/Usual Name: Ultrasonic Probe Cover (Sheath)
IV. Proprietary Names: CLK™ Int'l, Sanitary Latex Probe Cover
V. Establishment Registration Number: In progress
VI. Classification: Probe covers such as these are regulated as accessories to the devices on which they are intended to be used. These covers are designed to be used on various probes of Ultrasound Imaging Systems, especially those used in transvaginal or transrectal imaging. Therefore, they are regulated as Class II devices. One of the major instrument types on which they are used is the Ultrasonic Imaging System, pulsed echo, described in CFR 892.1560. Because of some latex problems, they are also regulated as latex products, similar to exam gloves which are often used in same body areas.
VI. Performance Standard:
None established under section 514.
VII. Description of the Device:
These devices are latex sheaths, closely related to condoms which have been used in the past for this purpose. However, these sheaths have different dimensions, depending on which probe they are designed to be used. They may range in size from about 30 cm. length, and 10 cm. in diameter to 6 cm. in length to 2 cm. in diameter with the 20 cm x 5 cm being the most common.
VII. Substantial Equivalence: The CLK Latex Probe Cover is substantially equivalent to devices currently on the market, cleared by the 510(k) process. The CLK Latex Ultrasound Cover is substantially equivalent to (for example) the following devices:
-
Civco Latex Ultrasound Sheaths, cleared under K-895614, by Civco Medical Instruments,
-
Civco Probe Cover, cleared under K-943393 by Civco Medical Instruments,
-
Kiltex Probe Covers, cleared under K-961029, by Kiltex Corporation, and
-
Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories.
-
Corometrics Sanitary latex Probe cover, cleared under K-900805 and/or K-920374 by Corometrics Medical Systems.
Characteristics of the CLK™ Latex Probe Covers are compared with those of other products currently on the market Table 1.
repl. pg. 7
1
The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
-
These products have the same intended use, to aid in avoiding contamination of ultrasonic probes by bodily fluids to facilitate cleaning of these probes. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.
-
The technological characteristics for this product are the same as those for the predicate devices and those currently on the market that are prepared from latex materials.
-
Descriptive information provided shows that the materials from which the CLK Ultrasound Probes are made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market. Tests show they meet the requirements of ASTM D3578-95 for latex exam gloves.
-
The FDA "Decision-Making Process" chart was used and appears in Attachment V.
Data used in determining substantial equivalence include those required by ASTM D3578-95, and biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1.
Summary of Test Data Used in Determining Equivalence: Physical characteristics, before and after aging, Biocompatibility characteristics.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 6 1998
George Q. Kuo, M.D. President CLK International, Inc. 28 East Broadway, 2nd FI New York, NY 10002
Re:
K974301 CLK Int'l Sanitary Latex Probe Cover Dated: January 7, 1998 Received: January 12, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Dr. Kuo:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). . You may, therefore, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 regulatory 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 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 marked 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) 594-4613. Additionally, for question 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" (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 http://www.fda.gov/odfk/dsmamain.html".---------------------------------------------------------------------------------------------
Sincerely vours.
h. Tiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
VIII.1 Indications for Use: [Separate Page]
510(k) Number:美味 K97430
Device Name: CLK™ Int'l. Sanitary Latex Probe Cover
- Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use________
(Optional Format 1-2-96)
epl. pg. 4
(Division Sign-Off)
Division of Reproductive, odominal. EN an Radiological Devic
) Number K974430
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