AFF (MARK I) VOLUMETRIC INFUSION PUMP

K070529 · Definitive Medical Technologies, Ltd. · FRN · May 8, 2007 · General Hospital

Device Facts

• Record ID: K070529
• Device Name: AFF (MARK I) VOLUMETRIC INFUSION PUMP
• Applicant: Definitive Medical Technologies, Ltd.
• Product Code: FRN · General Hospital
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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, and home care environments.

Device Story

AFF (MARK I) Volumetric Infusion Pump; delivers fluids, medications, TPN, and PCA. Uses peristaltic mechanism to pump fluids intravenously; compatible with standard IV sets. Operated in hospitals, ambulatory settings, nursing homes, and home care environments. Provides controlled fluid delivery to patients; supports clinical decision-making by ensuring precise medication administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Volumetric infusion pump; peristaltic pumping mechanism; compatible with standard IV sets; supports TPN and PCA operating modes.

Indications for Use

Indicated for patients requiring controlled infusion of medications, TPN, or PCA. Intended for use in hospital, ambulatory, nursing home, and home care settings.

Regulatory Classification

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.

Predicate Devices

• B. Braun Infusomatic Infusion Pump (K003029)
• Sigma International 8000 Infusion Pump (K950766)
• Baxter Flo-Gard Infusion Pump (K915522)

Submission Summary (Full Text)

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## MAY 8 2007 510(k) Summary

K070529

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. (a) | Submitter's<br>Corporate<br>Address: | Definitive Medical Technologies<br>4 Hamelacha St. North Industrial Zone<br>Lod, Israel 71520<br>www.definitive.com |
|--------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer<br>Address: | Definitive Medical Technologies, Ltd.<br>4 Hamelacha Street<br>North Industrial Zone Lod, Israel 71520 |
| | Mfg. Phone: | 972-8-925-1171 |
| | Contact Person: | Boaz Bartov CEO |
| | Date: | 12.12.06 |
| 2. | Device &<br>Classification<br>Name: | Infusion Pump (Class 2), Product Code FRN,<br>21 CFR 880.5725- Trade-name of device: AFF (MARK I) Volumetric<br>Infusion Pump |
| 3. | Predicate Devices: | B. Braun Infusomatic Infusion Pump (K003029)<br>Sigma International 8000 Infusion Pump (K950766)<br>Baxter Flo-Gard Infusion Pump (K915522) |
| 4. | Description: | The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump<br>is a medical device used to pump fluids into a patient in a controlled manner.<br>It is suitable for delivering a wide range of infusions, including medications,<br>as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient<br>Control Analgesia) operating modes. It is also compatible with the majority<br>of IV procedures and most standard IV sets. |
| 5. | Intended Use: | The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering<br>infusions of medications, as well as providing TPN (Total Parenteral<br>Nutrition) and PCA (Patient Control Analgesia). It is intended for use in<br>hospitals, ambulatory & nursing home (extended care) settings, or home<br>care environments. |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology, the AFF (MARK I) Volumetric Infusion Pump is<br>substantially equivalent to its predicate devices. All of the devices rely upon<br>peristaltic mechanisms to pump fluids intravenously through IV sets. The<br>manner of control and safety features for each device is similar. Extensive<br>testing has confirmed the performance and safety of the AFF (MARK I)<br>Volumetric Infusion Pump. |

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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

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