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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the PowrSyringe Aspirator, a piston syringe.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functionality in intended use	Confirmed (Non-Clinical Testing)
Equivalence to predicate device	Confirmed (Non-Clinical Testing)
No new safety risks compared to predicate devices	Confirmed (Non-Clinical Testing)
Equivalence in indications for use	Confirmed (Comparison to Predicate Devices)
Equivalence in intended use	Confirmed (Comparison to Predicate Devices)
Equivalence in patient contact materials	Confirmed (Comparison to Predicate Devices)
Equivalence in design	Confirmed (Comparison to Predicate Devices)
Equivalence in function	Confirmed (Comparison to Predicate Devices)
Equivalence in performance	Confirmed (Comparison to Predicate Devices)
Equivalence in sterilization	Confirmed (Comparison to Predicate Devices)
Equivalence in safety	Confirmed (Comparison to Predicate Devices)
Clear barrel for visualization of air bubbles	Safety feature included
Minimum dead space between plunger and barrel when handles are fully squeezed	Safety feature included
Handle design to prevent plunger from being pulled out of the barrel during aspiration	Safety feature included

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. The document states "Clinical testing: Not applicable." The performance testing mentioned is non-clinical. For non-clinical performance testing, the sample size is not specified in the provided text.
Data Provenance: Not applicable, as no clinical human data was used for testing. The testing was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical testing involving human data and therefore no ground truth established by experts in this context.

4. Adjudication method for the test set:

Not applicable. No clinical testing or expert adjudication was 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:

No. This device is a manual piston syringe, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is a physical, manual piston syringe, not an algorithm.

7. The type of ground truth used:

For the non-clinical performance testing, the ground truth would be based on engineering specifications, physical measurements, and functional requirements for a piston syringe, validated against established industry standards and the predicate devices' performance. The document doesn't explicitly state the specific "type" but implies objective physical and functional criteria.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, this is not an AI algorithm.

Summary

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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 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.

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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.

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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,

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

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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

Regulation Number and Section

§ 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).