(162 days)
The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of administration (e.g. intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, regional, or surgical wound site). The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
I regret to inform you that the documents you provided do not contain the specific information needed to fulfill your request.
The provided text is an FDA 510(k) clearance letter for the "BodyGuard Infusion Pump System." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not include details about:
- Acceptance criteria for device performance.
- A study describing performance results against those criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information regarding MRMC studies, standalone performance, or training set details.
The letter focuses on the regulatory clearance process and the device's indications for use, not the detailed performance studies or the methodology behind them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions based on the input text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, a symbol often associated with medicine and healthcare.
MAR 1 1 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gali Tzury Quality Assurance Manager Caesarea Medical Electronics Limited 16 Shacham Street Caesarca Industrial Park P.O. Box 4294 Caesarea 38900 ISRAEL
Re: K042696
Trade/Device Name: BodyGuard Infusion Pump System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA, MEA Dated: February 15, 2005 Received: February 22, 2005
Dear Mr. Tzury:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have revious Jour becatermined 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 Intelstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, on to devroes that nove of the (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls 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 IT your device is classinod (So ah additional controls. Existing major regulations affecting (1 Mrs), it may of suched in the Code of Federal Regulations. Title 21, Parts 800 to 898. In your device can be found ther announcements concerning your device in the Ecderal Register.
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Page 2 -- Mr. Tzury
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 mean that IDA has made a deceminary and regulations administered by other Federal agencies. of the Act of ally I ederal statues and regisms.
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Hee reg (21 CFR Part 801); good manufacturing practice. allit listing (21 CFR Part 007), lasting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by sections (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) I mis letter will anow you to begin mailering your
premarket notification. The FDA finding of substantial equivalence of your device to a premiarket nothreation. The PDF results in a classification for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your as at (240) 276-0115. Also, please note the regulation prease contact the Office or Somne to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general misterials and Consumer Assistance at its toll-free Dreision (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 ()ffice of Device Evaluation Center for Devices and Radiological Health
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Indications For Use
K042696 510(k) Number:
BodyGuard Infusion Pump System Device Name:
Indications for Use:
The BodyGuard infusion Pump system is designed for infusion of The DodyGuara mraston rang continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of precisery-controned intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, Chichai, Checrai, In- Chity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, Is Intended Tor patteral and enteral nutrition fluids, chemotherapeutic agents r CA therapy; pareral fluids therapy in hospital and home care environments.
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/ OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Chis 29
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 : : : : 03) Jedon Control. Dental Devices : Rumber ..
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• Caesarea Medical Electronics Ltd. • Traditional 510(k) Premarket Submission · BodyGuard Infusion Pump System · Confidential
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).