(80 days)
No
The device description and performance studies focus on mechanical function and basic pressure measurement, with no mention of AI or ML.
Yes
The device is described as an aspirator used to inject or aspirate fluids from the body, which are therapeutic actions.
No
The device is described as a piston syringe used to inject or aspirate fluids, and its functionality tests (e.g., leakage, fluid seal integrity) are related to fluid handling, not diagnostic determination. The addition of a pressure gauge does not inherently make it a diagnostic device without an indication that the pressure reading is used to diagnose a condition.
No
The device description clearly outlines a physical, hand-held aspirator with mechanical components (barrel, plunger, handles, pressure gauge). The performance studies also focus on physical and mechanical testing.
Based on the provided information, the Aspire Aspirator G 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 device used directly on or within the patient's body for therapeutic or diagnostic procedures, not for examining specimens outside the body.
- Device Description: The description details a mechanical device for fluid manipulation within the body (syringe, barrel, plunger, handles). There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD-specific information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
The device is clearly intended for direct interaction with the patient's body for fluid management, which falls under the category of medical devices used in vivo, not in vitro.
N/A
Intended Use / Indications for Use
The Aspire Aspirator G is a piston syringe to inject fluids into, or aspirate fluids from, the body.
Product codes
DXE, FMF
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
No clinical study is required or included.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
1
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
2
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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3
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
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.
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
5
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
| | Predicate
Control Medical Technology
Aspire Aspirator K072299 | Subject Device
Control Medical Technology
Aspire 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 piston
syringe to inject fluids into, or aspirate
fluids from, the body. | The Aspire Aspirator G is a piston
syringe to inject fluids into, or aspirate
fluids from, the body. | Same as Predicate. |
| Fundamental
Scientific Principle | The front handle is pivotally connected
to 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 front handle is pivotally connected
to 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. | Same as Predicate. |
| Mechanism | Handle design creates mechanical
advantage to move the plunger into
and out of the barrel. | Handle design creates mechanical
advantage to move the plunger into
and 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 Outer
Diameter | 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 & Barrel
Lubricant | Med 400 | Med 400 | Same as Predicate. |
| Plunger Retention? | Yes, Handle design prevents plunger
from being pulled out of barrel when
handles are fully squeezed. | Yes, Handle design prevents plunger
from being pulled out of barrel when
handles 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 together
polycarbonate | Two-piece snap together
polycarbonate | 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 separate
pressure gauge to the Predicate. | Subject Device includes a pressure
gauge. | Users may connect a separate
pressure gauge to the Predicate.
Same gauge as Reference
Device. |
| Drain Bag and
connecting 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 as
Predicate. |
| Sterilization | ETO | ETO | Same sterilization as Predicate. |
| Same Instruction for
Use? | Yes | Yes | Same IFU for Predicate and
Subject 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 new
materials. Barrels, plungers, and
tubing are the exact same as
Predicate. |
6
7
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 ●
-
- Clinical Tests. No clinical study is required or included.
-
- 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.