(74 days)
Not Found
No
The provided text describes a standard volumetric infusion pump and does not mention any AI or ML capabilities.
Yes
The device is used for delivering medications and nutritional support to a patient, which directly serves a therapeutic purpose.
No
The device, a Volumetric Infusion Pump, is described as delivering infusions of medications, TPN, and PCA, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is a "Volumetric Infusion Pump," which is a hardware device used to pump fluids. The description also mentions compatibility with "standard IV sets," further indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that the AFF (MARK I) Volumetric Infusion Pump is used to pump fluids into a patient. This is a therapeutic function, not a diagnostic one. It is delivering substances to the body, not analyzing samples from the body.
- Intended Use: The intended use is for delivering medications, TPN, and PCA, all of which are treatments or forms of nutritional support administered directly to the patient.
Therefore, based on the provided information, the AFF (MARK I) Volumetric Infusion Pump is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, or home care environments.
Product codes
FRN
Device Description
The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump is a medical device used to pump fluids into a patient in a controlled manner. It is suitable for delivering a wide range of infusions, including medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia) operating modes. It is also compatible with the majority of IV procedures and most standard IV sets.
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
hospitals, ambulatory & nursing home (extended care) settings, or home care environments.
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)
Extensive testing has confirmed the performance and safety of the AFF (MARK I) Volumetric Infusion Pump.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
B. Braun Infusomatic Infusion Pump (K003029), Sigma International 8000 Infusion Pump (K950766), Baxter Flo-Gard Infusion Pump (K915522)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY 8 2007 510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter's
Corporate
Address: | Definitive Medical Technologies
4 Hamelacha St. North Industrial Zone
Lod, Israel 71520
www.definitive.com |
|--------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | Definitive Medical Technologies, Ltd.
4 Hamelacha Street
North Industrial Zone Lod, Israel 71520 |
| | Mfg. Phone: | 972-8-925-1171 |
| | Contact Person: | Boaz Bartov CEO |
| | Date: | 12.12.06 |
| 2. | Device &
Classification
Name: | Infusion Pump (Class 2), Product Code FRN,
21 CFR 880.5725- Trade-name of device: AFF (MARK I) Volumetric
Infusion Pump |
| 3. | Predicate Devices: | B. Braun Infusomatic Infusion Pump (K003029)
Sigma International 8000 Infusion Pump (K950766)
Baxter Flo-Gard Infusion Pump (K915522) |
| 4. | Description: | The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump
is a medical device used to pump fluids into a patient in a controlled manner.
It is suitable for delivering a wide range of infusions, including medications,
as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient
Control Analgesia) operating modes. It is also compatible with the majority
of IV procedures and most standard IV sets. |
| 5. | Intended Use: | The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering
infusions of medications, as well as providing TPN (Total Parenteral
Nutrition) and PCA (Patient Control Analgesia). It is intended for use in
hospitals, ambulatory & nursing home (extended care) settings, or home
care environments. |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology, the AFF (MARK I) Volumetric Infusion Pump is
substantially equivalent to its predicate devices. All of the devices rely upon
peristaltic mechanisms to pump fluids intravenously through IV sets. The
manner of control and safety features for each device is similar. Extensive
testing has confirmed the performance and safety of the AFF (MARK I)
Volumetric Infusion Pump. |
1
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is that of an official or institutional heading.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
MAY 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Definitive Medical Technologies, Limited C/O Mr. J.A. Van Vugt Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K070529
Trade/Device Name: AFF (MARK I) Volumetric Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 1, 2007 Received: May 2, 2007
Dear Mr. Vugt:
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 Federal Register.
2
Page 2 -Mr. Vugt
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 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) 276-0115. 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.
Clare
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
3
Indications for Use
Konas29
510(k) Number (if known):
Device Name: AFF (MARK I) Volumetric Infusion Pump
Indications For Use: The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ahmir
Page 1 of 1 1105p. II 1 11.1 Acon Control. ි.
A Member, K479539 --------------------