The Subject Device is a single-use, hand-held, and general-purpose aspirator configured with a barrel, plunger, and handles. The front handle is pivotally connected the back handle and distally connected to the barrel. The back handle is pivotally connected to the front handle and distally connected to the plunger. Squeezing the handles creates a mechanical advantage to move the plunger inside the barrel. The handle design also prevents the plunger from being pulled completely out of the barrel during use. The main difference between the Subject Device and the Predicate is the addition of a basic off-the-shelf pressure gauge and change from a one-piece to two-piece button between the handles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Aspire Mechanical Aspirator G based on the provided FDA 510(k) summary:

The document describes non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study of AI performance. Therefore, many of the requested categories related to AI performance, human readers, and ground truth establishment (which are typically relevant for AI/ML device submissions) are not applicable here.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by confirming the Subject Device performs the same as the Predicate device across various bench tests. The reported performance is that the Subject Device confirms to these tests.

Acceptance Criterion (Implicitly "Same as Predicate")	Reported Subject Device Performance
Operational & Actuation Tests	Confirmed
Vacuum Integrity Tests	Confirmed
ISO 7886-1:2017 Annex B Barrel Leakage Tests	Confirmed
ISO 7886-1:2017 Annex B Plunger Leakage Tests	Confirmed
ISO 7886-1:2017 Annex B Luer Leakage Tests	Confirmed
ISO 80369-20:2015 Annex D Fluid Seal Integrity Tests	Confirmed
MIL-STD-1472F Button Force Tests	Confirmed
ISO 10993-1 Biocompatibility	Confirmed
ISO 11135-1:2014 Sterilization to achieve SAL 106 and EO/ECH limits below ISO 10993-7 standards	Confirmed
ISO 1167-1:2006 Packaging Integrity Tests	Confirmed
ASTM F1608 Package Integrity Tests	Confirmed
ASTM D4169 Shipping Integrity Tests	Confirmed

Study Details (Non-Clinical Bench Testing)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The tests listed are standard for medical devices of this type and would typically involve a statistically relevant number of units, but the specific quantity is not given.
- Data Provenance: Not applicable as this is bench testing of physical device performance, not data-driven AI. The tests confirm manufacturing standards and device functionality.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device, and performance is measured against established engineering standards (e.g., ISO, ASTM, MIL-STD) and predicate device performance, not expert human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is objective bench testing against measurable standards, not subjective human assessment requiring adjudication.
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 a mechanical aspirator, a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device; there is no algorithm or AI component. The "standalone" performance here refers to the device itself operating according to its design specifications.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device is defined by engineering specifications and recognized industry standards (e.g., ISO, ASTM, MIL-STD) for performance characteristics like leakage, force, and sterilization efficacy. The predicate device's established performance also serves as a benchmark for equivalence.
The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 29, 2020

Control Medical Technology Shawn Fojtik President 2757 South 300 West Suite F (ZIEN) Salt Lake City, Utah 84115

Re: K200629

Trade/Device Name: Aspire Mechanical Aspirator G Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 30, 2020 Received: May 01, 2020

Dear Shawn Fojtik:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Alan Stevens Assistant Director THT3C1: Injection Devices DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary K200629

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.

1. Submitter

Control Medical Technology 2757 South 300 West Salt Lake City, Utah 84115 USA Phone (383) 444-2666

FDA Establishment Registration Number: #3007282893

Contact

Control Medical Technology 2757 South 300 West Salt Lake City, Utah 84115 USA Phone (383) 444-2666

Date of Preparation: May 28, 2020

2. Subject Device

Trade Name:

Common Name: Classification Name: Product Code: Regulation:

Aspire Mechanical Aspirator G ("Aspire Aspirator G" and/or "Subject Device") Syringe and Aspirator Syringe, Piston FMF Class II, 21 CFR 880.5860

3. Predicate Device

Trade Names:

Common Name: Classification Name: Product Code: Regulation:

Aspire Mechanical Aspirator K072299 ("Aspire Aspirator" and/or "Predicate") Syringe and Aspirator Syringe, Piston FMF Class II, 21 CFR 880.5860

Image /page/3/Picture/18 description: The image shows a medical device labeled as a "PREDICATE DEVICE". The device appears to be a type of aspirator, specifically an "Aspire Aspirator". The text below the device also includes the numbers "K072299. Also K113757 and K131998".

Image /page/3/Picture/19 description: The image shows a close-up of a medical device labeled as a "Subject Device". The device appears to be a hand-operated aspirator, possibly used for suctioning fluids. It features a clear cylindrical chamber, a pressure gauge on top, and a black handle with a lever mechanism for creating suction. The text "Aspire Aspirator G" is visible at the bottom of the image.

Page 1 of 5 Section 5 510k Summary

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4. Reference Device

Trade Name:	PowrSyringe K072345
Common Name:	Syringe and Aspirator
Classification Name:	Syringe, Piston
Product Code:	FMF
Regulation:	Class II, 21 CFR 880.5860

Reference device utilized in submission because the pressure gauge is the same material, assembly, and processes as Subject Device.

5. Device Description

Image /page/4/Picture/7 description: The image shows two medical devices, labeled as "PREDICATE DEVICE" and "SUBJECT DEVICE". The "PREDICATE DEVICE" is identified as "Aspire Aspirator K072299. Also K113757 and K131998". The "SUBJECT DEVICE" is identified as "Aspire Aspirator G". Both devices appear to be hand-operated suction devices with a similar design, featuring a handle and a clear cylinder.

The Subject Device's design, intended use, fundamental scientific principle, operation, technology, actuation, use, barrel, plunger, front handle, button, dimensions, luers, connectors, polymers, molding, assembly, packaging, and sterilization is the same as the Predicate. Users may connect pressure gauges to Predicate during use. The main difference between the Subject Device and the Predicate is the addition of a basic off-the-shelf pressure gauge and change from a one-piece to two-piece button between the handles.

6. Indications for Use

The Subject Device is the same Indication as the Predicate: The Subject Device is a piston syringe to inject fluids into, or aspirate fluids from, the body.

7. Comparison to Predicate Devices

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The Subject Device is substantially equivalent to the Predicate based on equivalence in:

Same Science Same Fundamental Scientific Principle

Same Device Construction

Design Mechanical Function Valves Barrels Handles
Mechanism of Action Manufacturing Dimensions Plungers

Same Labeling

Same Indication for Use Warnings

Instructions for Use

Same Manufacturing

Molding Packaging Assembly Sterilization

	PredicateControl Medical TechnologyAspire Aspirator K072299	Subject DeviceControl Medical TechnologyAspire Aspirator G	Comments
Common Name	Syringe and Aspirator	Syringe and Aspirator	Same as Predicate.
Classification Name	Syringe, Piston	Syringe, Piston	Same as Predicate.
Committee	General Hospital	General Hospital	Same as Predicate.
FDA Product Code	FMF	FMF	Same as Predicate.
Regulation	Class II, 21 CFR 880.5860	Class II, 21 CFR 880.5860	Same as Predicate.
Intended Use	The Aspire Aspirator is a pistonsyringe to inject fluids into, or aspiratefluids from, the body.	The Aspire Aspirator G is a pistonsyringe to inject fluids into, or aspiratefluids from, the body.	Same as Predicate.
FundamentalScientific Principle	The front handle is pivotally connectedto the back handle and distallyconnected to the barrel. The backhandle is pivotally connected to thefront handle and distally connected tothe plunger. Squeezing the handlescreates a mechanical advantage tomove the plunger inside the barrel.The handle design also prevents theplunger from being pulled completelyout of the barrel during use.	The front handle is pivotally connectedto the back handle and distallyconnected to the barrel. The backhandle is pivotally connected to thefront handle and distally connected tothe plunger. Squeezing the handlescreates a mechanical advantage tomove the plunger inside the barrel.The handle design also prevents theplunger from being pulled completelyout of the barrel during use.	Same as Predicate.
Mechanism	Handle design creates mechanicaladvantage to move the plunger intoand out of the barrel.	Handle design creates mechanicaladvantage to move the plunger intoand out of the barrel.	Same as Predicate.
User Control	Manual	Manual	Same as Predicate.
Barrels	Polycarbonate	Polycarbonate	Same as Predicate.
Barrel Volume	30ml	30ml	Same as Predicate.
Barrel Length	9.5cm	9.5cm	Same as Predicate.
Barrel OuterDiameter	3.5cm	3.5cm	Same as Predicate.
Barrel Tip	ISO Luer lock	ISO Luer lock	Same as Predicate.
Plunger	Polycarbonate	Polycarbonate	Same as Predicate.
Plunger Length	12cm	12cm	Same as Predicate.
O-ring	Yes	Yes	Same as Predicate.
O-ring & BarrelLubricant	Med 400	Med 400	Same as Predicate.
Plunger Retention?	Yes, Handle design prevents plungerfrom being pulled out of barrel whenhandles are fully squeezed.	Yes, Handle design prevents plungerfrom being pulled out of barrel whenhandles are fully squeezed.	Same as Predicate.
Front Handle	Two-piece polycarbonate	Two-piece polycarbonate	Same as Predicate.
Front Handle Length	16.75cm	16.75cm	Same as Predicate.
Front Handle Width	1.75cm	1.75cm	Same as Predicate.
Back Handle	Two-piece snap togetherpolycarbonate	Two-piece snap togetherpolycarbonate	Same as Predicate.
Back Handle Length	16.50cm	16.50cm	Same as Predicate.
Back Handle Width	1.75cm	1.75cm	Same as Predicate.
Spring	Torsion spring	Torsion spring	Same as Predicate.
Pressure Gauge	Users may connect a separatepressure gauge to the Predicate.	Subject Device includes a pressuregauge.	Users may connect a separatepressure gauge to the Predicate.Same gauge as ReferenceDevice.
Drain Bag andconnecting tubing?	Yes >250ml	Yes >250ml	Same as Predicate.
Valve at tip?	Yes	Yes	Same as Predicate.
Valve at plunger?	Yes	Yes	Same as Predicate.
Packaging	Tray, Tyvek Lid, and Box	Tray, Tyvek Lid, and Box	Same Tray, Tyvek lid, and Box asPredicate.
Sterilization	ETO	ETO	Same sterilization as Predicate.
Same Instruction forUse?	Yes	Yes	Same IFU for Predicate andSubject Device.
Single Use Device?	Yes, Single Use	Yes, Single Use	Same as Predicate.
Bio-compatibility?	Yes. ISO 10993 compliant	Yes. ISO 10993 compliant	Same as Predicate. No newmaterials. Barrels, plungers, andtubing are the exact same asPredicate.

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8. Non-clinical Tests.

Bench testing confirms the Subject Device performs same as the Predicate including:

Operational & Actuation Tests
Vacuum Integrity Tests ●
ISO 7886-1:2017 Annex B Barrel Leakage Tests ●
ISO 7886-1:2017 Annex B Plunger Leakage Tests
ISO 7886-1:2017 Annex B Luer Leakage Tests ●
ISO 80369-20:2015 Annex D Fluid Seal Integrity Tests
MIL-STD-1472F Button Force Tests
ISO 10993-1 Biocompatibility
ISO 11135-1:2014 Sterilization to achieve SAL 106 and EO/ECH limits below ISO ● 10993-7 standards
ISO 1167-1:2006 Packaging Integrity Tests ●
ASTM F1608 Package Integrity Tests ●
ASTM D4169 Shipping Integrity Tests ●
1. Clinical Tests. No clinical study is required or included.
1. Conclusion. The Subject Device is substantially equivalent to the Predicate based on comparison of the device classification, product code, basic operating principle, fundamental scientific technology, indication for use, technical characteristics, packaging, and sterilization methods. Testing confirms the suitability of Subject Device for its intended use.

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).