(106 days)
The Syringe•Mate System is indicated for patients requiring slow, continuous intravenous, epidural, or subcutaneous administration of medications.
The new device consists of a line of Syringe•Mate System infusion pumps which will be manufactured with three different fixed, flow rates: *One Day Syringe•Mate System (4.2 mL/hr) *Five Day Syringe®Mate System (0.8 mL/hr) *Seven Day Syringe . Mate System (0.6 mL/hr)
The provided text describes a 510(k) premarket notification for the Syringe•Mate System. It focuses on demonstrating substantial equivalence to predicate devices based on material composition, overall design, and intended use. The document includes a summary of nonclinical tests but does not provide specific acceptance criteria or a detailed study report that proves the device meets those criteria in the format requested.
Therefore, many of the requested fields cannot be directly extracted or inferred from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological and Chemical Reactivity | Biological methods specified in ISO 10993-1 and USP Physicochemical tests acceptable for intended use. | Materials found to be acceptable for their intended use. |
| Functional Performance (Flow Rate) | Not explicitly stated (e.g., within X% of target flow rate) | Data generated; performance testing results indicate the system meets or exceeds functional requirements. |
| Functional Performance (Residual Volume) | Not explicitly stated | Data generated; performance testing results indicate the system meets or exceeds functional requirements. |
| Functional Performance (Pressure Relief Valve) | Not explicitly stated | Data generated; performance testing results indicate the system meets or exceeds functional requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the tests.
- Data Provenance: Not specified. It's likely internal testing by Baxter Healthcare Corporation, but a country of origin or retrospective/prospective nature is not mentioned.
3. 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. This device is a medical pump, not an AI/diagnostic device that requires expert-established ground truth for image/data interpretation. The testing focuses on physical and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. 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
- No. This is not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The performance testing is analogous to "standalone" in that it assesses the device's inherent function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biological/chemical tests: Compliance with ISO 10993-1 and USP Physicochemical tests serves as the "ground truth" or standard.
- For functional tests (flow rate, residual volume, pressure relief valve): Presumably, the engineering specifications and design requirements for these parameters serve as the "ground truth" against which performance is measured.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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510(k) Premarket Notification Syringe•Mate System
510(k) SUMMARY Syringe•Mate System
JUL 1 5 1997
Submitted by:
Patricia S. Barsanti Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared: March 29, 1997
Proposed Device: Syringe•Mate System
Predicate Devices: Uni.Dose Infusion Pump Baxter Multiday Infusor
Proposed Device Description:
The new device consists of a line of Syringe•Mate System infusion pumps which will be manufactured with three different fixed, flow rates:
*One Day Syringe•Mate System (4.2 mL/hr) *Five Day Syringe®Mate System (0.8 mL/hr) *Seven Day Syringe . Mate System (0.6 mL/hr)
Summary of Technological Characteristics of New Device to Predicate Devices
The Syringe. Mate System differs in material composition but is the same in overall design and intended use as the predicate devices.
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Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
The biological and chemical reactivity of the new materials have been assessed using biological methods specified in ISO 10993-1 and USP Physicochemical tests. The materials were found to be acceptable for their intended use.
Data regarding the functional performance of the Syringe•Mate System have also been generated. Testing was conducted to evaluate flow rate, residual volume and pressure relief valve performance. Performance testing results indicate that the Syringe Mate System meets or exceeds the functional requirements and supports its suitability for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia S. Barsanti, RAC Requlatory Affairs Manager Baxter Healthcare Corporation P.O. Box 490 Route 120 and Wilson Road Round Lake, Illinois 60073
JUL 1 5 1997
K971168 Re : One~Day/Five-Day/Seven-Day Syringe Mate Trade Name: Regulatory Class: Unclassified Product Code: MEB Dated: June 19, 1997 Received: June 24, 1997
Dear Ms. Barsanti:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
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Page 2 - Ms. Barsanti
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.ffa.gov/cdrh/dsmamain.html".
Sincerely yours,
Clatrust
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number: | Not Available K971168 |
|---|---|
| Device Name: | Syringe Mate System (Models 2C1141, 2C1142, 2C1143) |
| Indications for Use: | The Syringe•Mate System is indicated for patientsrequiring slow, continuous intravenous, epidural, orsubcutaneous administration of medications. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patacia Cucenti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K971168
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_
§ 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).