(31 days)
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No
The description details a purely mechanical syringe with a pressure gauge. There is no mention of any computational or data-driven components that would suggest AI/ML.
No.
The device is described as a syringe for injecting fluids and monitoring pressure, which are procedural tools rather than a treatment for a disease or condition.
No.
The device injects fluids and monitors pressure, which are interventional or functional actions, not diagnostic. While pressure monitoring can be part of a diagnostic procedure (like discography), the device itself is a tool for the procedure, not for generating a diagnosis.
No
The device description explicitly states it is a "single use manual hand-held piston syringe with handles and a pressure gauge," indicating it is a physical hardware device.
Based on the provided information, the PowrSyringe Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- PowrSyringe Monitor's Function: The description clearly states the PowrSyringe Monitor is a syringe used to inject fluids and monitor the pressure of that fluid within the body (specifically mentioning inflation and discography). It is a tool for delivering substances and measuring pressure in vivo, not for analyzing samples in vitro.
The device's function is entirely focused on direct interaction with the patient's body for therapeutic or diagnostic procedures involving fluid injection and pressure monitoring. This falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
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:
- 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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.
2
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