(86 days)
Not Found
Not Found
No
The summary describes a mechanical system for blood sampling and pressure monitoring, with no mention of AI or ML.
No
The device is described as a system for monitoring hemodynamic pressure and drawing blood samples, not for treating a disease or condition.
No
The device is described as a "hemodynamic pressure monitoring and blood gas sampling system," which are functions typically associated with collecting information about a patient's physiological state, but the primary function described is "easy withdrawal of blood samples from an arterial pressure monitoring line." While analyses might be performed on these samples, the device itself is a sampling system, not a device that performs the diagnostic analysis or interpretation. It facilitates the collection of samples for later diagnosis.
No
The device is described as a "hemodynamic pressure monitoring and blood gas sampling system" and an "Arterial Blood Sampling Set," which strongly implies physical components for blood withdrawal and pressure monitoring, not just software.
Based on the provided information, the HemoDraw™ Arterial Blood Sampling Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for sampling blood from an arterial line and monitoring hemodynamic pressure. While blood is being sampled, the primary function described is related to the collection and handling of the sample within a closed system and monitoring the patient's physiological state (hemodynamic pressure).
- Lack of Diagnostic Function: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. The description of the HemoDraw™ does not mention any analysis or testing of the blood sample itself to provide diagnostic information. It's a tool for obtaining the sample and monitoring pressure.
Therefore, the HemoDraw™ Arterial Blood Sampling Set appears to be a device used in the collection and management of blood samples and physiological monitoring, rather than a device that performs diagnostic testing on those samples.
N/A
Intended Use / Indications for Use
The HemoDraw™ 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.
Product codes
CBT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes, resembling a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2007
Ms. Barbara Law Regulatory Affairs Manager Smiths Medical ASD, Incorporated 6250 Shier Rings Road Dublin, Ohio 43016
Re: K071269
Trade/Device Name: HemoDraw™ Arterial Blood Sampling Set Regulation Number: 868.1100 Regulation Name: Arterial Blood Sampling Kit Regulatory Class: II Product Code: CBT Dated: July 18, 2007 Received: July 20, 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 (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 such 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 Eederal Register.
1
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 (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 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 (240) 276-0120. 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 vours.
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
2
SECTION 4: Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: HemoDraw™ Arterial Blood Sampling Set
Indications for Use:
The HemoDraw™ 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)
L
(acting B.C.)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:
Page 1 of
11