(48 days)
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No
The device description and intended use describe a simple manual syringe with no mention of AI or ML capabilities.
No.
The device is a general-purpose piston syringe for injecting or aspirating fluids, without any mentioned therapeutic function or claim.
No
Explanation: The device is described as a piston syringe for injecting or aspirating fluids from the body. Its function is to facilitate the movement of fluids, not to diagnose a condition or disease.
No
The device description clearly describes a physical, manual hand-held piston syringe with handles, barrel, and plunger, indicating it is a hardware device.
Based on the provided information, the PowrSyringe Aspirator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into, or aspirate fluids from, the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for examining samples outside the body.
- Device Description: The description details a manual hand-held piston syringe for fluid manipulation within the body. There is no mention of collecting, preparing, or analyzing biological samples in vitro.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The PowrSyringe Aspirator is a general-purpose medical device used for fluid management within the body, falling under the category of a syringe, which is not an IVD.
N/A
Intended Use / Indications for Use
The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from, the body.
Product codes
FMF
Device Description
The PowrSyringe Aspirator is a single use manual hand-held general-purpose piston syringe with handles to inject fluids into, or aspirate fluid from. The PowrSyringe Aspirator handles allow the user to pull the plunger back within the barrel when the user squeezes the handles. Users may open the PowrSyringe Aspirator's handles to inject fluids back into the barrel.
The PowrSyringe Aspirator 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)
Non-Clinical Testing: Performance testing to confirm functionality in the intended use and equivalence to predicate device is included.
Clinical testing: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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
510(k) Premarket Notification
5. 510(k) Summary
672299
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 Aspirator |
|---|---|
| Common Name: | Piston Syringe |
| Classification Name: | FMF Syringe, Piston |
(OCT 4 - 2007
Predicate Devices
The PowrSyringe Aspirator is substantially equivalent to multiple previous cleared piston syringe devices.
Device Description
The PowrSyringe Aspirator is a single use manual hand-held general-purpose piston syringe with handles to inject fluids into, or aspirate fluid from. The PowrSyringe Aspirator handles allow the user to pull the plunger back within the barrel when the user squeezes the handles. Users may open the PowrSyringe Aspirator's handles to inject fluids back into the barrel.
The PowrSyringe Aspirator safety features include:
- Clear barrel for visualization of air bubbles. 에
- 미 Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- E Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
Intended Use
The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from. the body.
Comparison to Predicate Devices
Data is provided to demonstrate the PowrSyringe Aspirator 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
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/1 description: The image shows a partial view of the Department of Health & Human Services (HHS) seal. The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles arranged in a row, with the first profile being the most complete and the subsequent profiles gradually fading away. The profiles are all facing to the right.
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
OCT A 2007
Re: K072299 Trade/Device Name: PowrSyringe Aspirator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 19, 2007 Received: September 20, 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,
Qurs
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
3
4. Indication for Use Statement
510(k) Number:
072299 K
Device Name:
PowrSyringe Aspirator
Indications for Use:
The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from, the body.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Anthen V,ma
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 472299