(436 days)
The [ SURE™ ] probe cover is intended to be placed on Ultrasound Probes used in natural body orifices such as vagina to facilitate cleaning and sanitization of the probe.
SURE ™ Latex Ultrasonic Probe Cover
This document is a 510(k) clearance letter from the FDA for a medical device called "SURE™ Latex Ultrasonic Probe Cover". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, not performance metrics derived from a study.
Therefore, I cannot provide the requested information based on this document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a black and white logo. The logo is circular and contains an abstract image of an eagle. The eagle is facing left and has three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2003
Mr. Koi Yong Lim Director Pleasure Latex Products SDN.BHD Lot 2401, 17th Miles Jalan Sungai Sembilang 45800 Jeram, Selangor Darul Ehsan MALAYSIA
Re: K022156
Trade/Device Name: SURE™ Latex Ultrasonic Probe Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: June 28, 2003
Received: August 20, 2003
Dear Mr. Lim:
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 legally 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 application (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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
This letter will allow you to begin 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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
VII. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | |
|---|---|
| Device | SURE ™ Latex Ultrasonic Probe Cover |
| Indications For Use: | The [ SURE™ ] probe cover is intended to be placed on Ultrasound Probes used in natural body orifices such as 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 (Per 21 CFR β 801.109)
OR
Over-The-Counter Use
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdon inal. and Radiological Devices 510(k) Number _
Page 11 of 11
§ 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.