(37 days)
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The document is an FDA 510(k) clearance letter for the "SECURE® Arterial Blood Sampling Set." This letter primarily:
- Acknowledges the review of the premarket notification.
- States that the device is substantially equivalent to legally marketed predicate devices.
- Outlines general regulatory requirements and responsibilities for the manufacturer.
- Includes the "Indications for Use" statement for the device.
It does not contain:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test or training sets.
- Information about experts used for ground truth or adjudication methods.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established.
Therefore, I cannot provide the requested information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Law Regulatory Affairs Manager Smiths Medical ASD, Incorporated 6250 Shier Rings Road Dublin, Ohio 40316
MAR 1 5 2007
Re: K070340
Trade/Device Name: SECURE® Arterial Blood Sampling Set Regulation Number: 868.1100 Regulation Name: Arterial Blood Sampling Kit Regulatory Class: II Product Code: CBT Dated: February 5, 2007 Received: February 9, 2007
Dear Ms. Law:
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(first 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 such additional controls. Existing major reguly for sasferting 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 Foderal Register.
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Page 2 -Ms. Law
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.
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 vour 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/industry/support/index.html.
Sincerely yours,
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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SECTION 4: Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: SECURE® Arterial Blood Sampling Set
Indications for Use:
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chas Or
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§ 868.1100 Arterial blood sampling kit.
(a)
Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.