(74 days)
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.
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.
This 510(k) summary describes a medical device, an infusion pump, which does not typically involve the types of acceptance criteria and study designs that are common for AI/ML-driven diagnostic devices (e.g., those involving image analysis or predictive analytics). Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from the provided text.
Specifically, there is no mention of algorithms, AI, machine learning, ground truth, experts establishing ground truth, training sets, test sets, or comparative effectiveness studies with human readers. The document focuses on the substantial equivalence of a physical medical device (an infusion pump) based on its technological characteristics and performance testing against predicate devices.
However, I can extract information related to the device's function and the general nature of its performance evaluation, as much as is available in the provided text.
Acceptance Criteria and Study for Definitive Medical Technologies AFF (MARK I) Volumetric Infusion Pump
Based on the provided 510(k) summary, the device is an infusion pump, and its acceptance criteria and study are focused on its mechanical and functional performance, safety, and substantial equivalence to existing predicate devices.
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A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Extensive testing has confirmed the performance and safety of the AFF (MARK I) Volumetric Infusion Pump" and that it is "substantially equivalent to its predicate devices" with respect to technology and safety features.
- Note: For this type of device, performance criteria typically relate to flow rate accuracy, occlusion pressure detection, air-in-line detection, alarm functions, battery life, material biocompatibility, electromagnetic compatibility (EMC), and mechanical durability, as outlined in relevant standards for infusion pumps (e.g., IEC 60601-2-24). However, these specific details are not present in the 510(k) summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of device and submission. The "test set" in this context would refer to the physical testing of the infusion pump itself, not a dataset for an algorithm. The document does not specify the number of units tested, the origin of such testing, or whether it was prospective or retrospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The concept of "ground truth" established by experts for a test set is relevant to diagnostic or AI/ML devices. For an infusion pump, performance is measured against engineering specifications and international standards, not against expert consensus on a dataset.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations of data, which is not relevant to the performance evaluation of an infusion pump.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC study involves human readers (e.g., radiologists, pathologists) interpreting cases, often with or without AI assistance, to assess diagnostic performance. This is irrelevant for an infusion pump, which is a physical device for delivering fluids.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no mention of an algorithm or AI component in this infusion pump.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The performance of an infusion pump is assessed against its functional specifications and safety standards, not against "ground truth" derived from expert consensus, pathology, or outcomes data.
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The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
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How the ground truth for the training set was established
Not applicable. There is no training set or ground truth for a training set discussed.
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MAY 8 2007 510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter'sCorporateAddress: | Definitive Medical Technologies4 Hamelacha St. North Industrial ZoneLod, Israel 71520www.definitive.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | Definitive Medical Technologies, Ltd.4 Hamelacha StreetNorth Industrial Zone Lod, Israel 71520 |
| Mfg. Phone: | 972-8-925-1171 | |
| Contact Person: | Boaz Bartov CEO | |
| Date: | 12.12.06 | |
| 2. | Device &ClassificationName: | Infusion Pump (Class 2), Product Code FRN,21 CFR 880.5725- Trade-name of device: AFF (MARK I) VolumetricInfusion 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 Pumpis 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 (PatientControl Analgesia) operating modes. It is also compatible with the majorityof IV procedures and most standard IV sets. |
| 5. | Intended Use: | The AFF (MARK I) Volumetric Infusion Pump is indicated for deliveringinfusions of medications, as well as providing TPN (Total ParenteralNutrition) and PCA (Patient Control Analgesia). It is intended for use inhospitals, ambulatory & nursing home (extended care) settings, or homecare environments. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology, the AFF (MARK I) Volumetric Infusion Pump issubstantially equivalent to its predicate devices. All of the devices rely uponperistaltic mechanisms to pump fluids intravenously through IV sets. Themanner of control and safety features for each device is similar. Extensivetesting has confirmed the performance and safety of the AFF (MARK I)Volumetric Infusion Pump. |
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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.
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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 (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
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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
Page 1 of 1 1105p. II 1 11.1 Acon Control. ි.
A Member, K479539 --------------------
§ 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).