(31 days)
The PowrSyringe Monitor is a piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography.
The PowrSyringe Monitor is a single use manual hand-held piston syringe with handles and a pressure gauge to inject fluids and monitor the pressure of that fluid including use in inflation and discography. The PowrSyringe Monitor handles allow the user to push the plunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Monitor's handles to aspirate fluid back into the barrel.
The PowrSyringe Monitor safety features include:
- Clear barrel for visualization of air bubbles.
- Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
The provided text details a 510(k) submission for the "PowrSyringe Monitor," a piston syringe. However, it explicitly states that "Clinical testing is not applicable" for this device. Therefore, a study proving the device meets acceptance criteria, as typically understood in a clinical trial context with performance metrics, ground truth, and statistical analysis, was not conducted or required for this submission.
The acceptance criteria described for this device are focused on substantial equivalence to predicate devices through non-clinical (bench and animal) performance testing and demonstrating that it "does not introduce any new safety risks."
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments from Text |
|---|---|---|
| Equivalence in Indications for Use | "Substantial equivalence is based on equivalence in indications for use..." | The device is a "piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography," which is deemed equivalent to predicate devices. |
| Equivalence in Intended Use | "Substantial equivalence is based on equivalence in...intended use..." | Same as above. |
| Equivalence in Patient Contact | "Substantial equivalence is based on equivalence in...patient contact..." | Not specifically detailed, but implied to be similar to predicate devices. |
| Equivalence in Materials | "Substantial equivalence is based on equivalence in...materials..." | Not specifically detailed, but implied to be similar to predicate devices. |
| Equivalence in Design | "Substantial equivalence is based on equivalence in...design..." | Key design features mentioned: clear barrel, minimum dead space, handle design to prevent plunger pull-out. Implied to be equivalent to predicate. |
| Equivalence in Function | "Substantial equivalence is based on equivalence in...function..." | Function: "inject fluids and monitor the pressure." Implied to be equivalent to predicate. |
| Equivalence in Performance (Non-Clinical) | "Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included." | Specific performance metrics from these tests are not provided in the summary. |
| Equivalence in Sterilization | "Substantial equivalence is based on equivalence in...sterilization..." | Not specifically detailed, but implied to be similar to predicate devices. |
| Equivalence in Safety | "Substantial equivalence is based on equivalence in...safety." Also, "does not introduce any new safety risks." | Safety features mentioned: clear barrel, minimum dead space, handle design. Implied to be equivalent or better in safety than predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable for clinical testing as none was performed. For non-clinical (bench and animal) testing, the sample sizes are not specified in the provided summary.
- Data Provenance: Not applicable for clinical testing. For non-clinical testing, the provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as clinical testing with human experts for ground truth was not performed.
4. Adjudication method for the test set
- Not applicable as clinical testing was not performed.
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
- Not applicable. This device is a manual piston syringe, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual piston syringe, not an algorithm.
7. The type of ground truth used
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established by engineering specifications, validated test methods, and direct measurement of physical properties and performance during bench and animal testing.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document relates to a 510(k) submission for a medical device (a syringe) where substantial equivalence was demonstrated through non-clinical testing, and clinical testing was deemed unnecessary. Therefore, the questions related to clinical study design, performance metrics, and AI/ML model validation are not applicable in this context.
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5. 510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR $807), and in particular $807.92, the following summary of safety and effectiveness information is provided.
Device Information
| Trade Name: | PowrSyringe Monitor |
|---|---|
| Common Name: | Piston Syringe |
| Classification Name: | FMF Syringe, Piston |
Predicate Devices
The PowrSyringe Monitor is substantially equivalent to multiple previous cleared piston. inflation, and pressure monitoring syringes.
Device Description
The PowrSyringe Monitor is a single use manual hand-held piston syringe with handles and a pressure gauge to inject fluids and monitor the pressure of that fluid including use in inflation and discography. The PowrSyringe Monitor handles allow the user to push the plunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Monitor's handles to aspirate fluid back into the barrel.
The PowrSyringe Monitor safety features include:
- 제 Clear barrel for visualization of air bubbles.
- 트 Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- 다 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
Intended Use
The PowrSyringe Monitor is a piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography.
Comparison to Predicate Devices
Data is provided to demonstrate the PowrSyringe Monitor is substantially equivalent to previous cleared devices and does not introduce any new safety risks. Substantial equivalence is based on equivalence in indications for use, intended use, patient contact, materials, design, function, performance, sterilization, and safety.
Non-Clinical Testing
Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included.
Clinical testing
Not applicable.
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SEP 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pinyons Medical Technology, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313
Re: K072345
Trade/Device Name: PowrSyringe Monitor Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 5, 2007 Received: September 6, 2007
Dear Mr. Job:
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. Job
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Satic Y. Michael Dmd.
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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4. Indication for Use Statement
510(k) Number:
\$\phi72345
Device Name:
PowrSyringe Monitor
Indications for Use:
The PowrSyringe Monitor is a piston syringe to inject fluids and monitor the pressure of that fluid including use in inflation and discography.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Anthony D. m
(Division of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ K473345
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).