The XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.

Device Description

The XPRESSE Assist Device is a non-sterile, air/gas-powered device that is used to assist the clinician in dispensing the contents of a prefilled piston syringe into the body. The clinician connects the XPRESSE Assist Device to the desired syringe, and uses the foot pedal to activate the XPRESSE Assist Device. When activated by the foot pedal, the XPRESSE Assist Device allows flow of compressed air/gas, which pushes the syringe plunger forward, dispensing the syringe contents. The XPRESSE Assist Device is compatible with standard glass or plastic barrel syringes.

The XPRESSE Assist Device includes the following components:

a controller to provide regulated, compressed air/gas to a syringe (syringe not a part of this device),
a foot switch connecting to the control unit for clinician activation of the system, and
a disposable adaptor and tubing unit, with integral plastic tube connecting the controller to the desired syringe.

The controller includes an electrically-powered LED display to indicate system pressure settings and to allow activation/inactivation of the foot pedal. Pressure is adjustable by the clinician from 0 to 100 psi using the controller knob located on the front face plate of the controller. The XPRESSE Assist Device is compatible with either a compressed air canister (45-gram CO2) or facility compressed air.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the XPRESSE Assist Device, focusing on acceptance criteria and supporting studies:

This summary is for a medical device that assists in administering materials via a syringe (a hardware device), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria (e.g., number of experts for ground truth, sample size for training data, MRMC studies) are not applicable to this type of submission. The device falls under Class II with product code FMF (Piston Syringe).

The core of its clearance is establishing substantial equivalence to predicate devices, focusing on safety and performance as a hardware accessory.

Acceptance Criteria and Reported Device Performance

Given that this is a hardware device focused on assisting manual injection, the "acceptance criteria" are interpreted as compliance with relevant medical device standards and demonstrating performance equivalent or superior to the predicate devices in terms of force application and control.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance	Comments
Electrical Safety	IEC 60601-1 (General Requirements for Safety, 1988; Amends 1991, 1995)	Passed	Demonstrates compliance with fundamental electrical safety for medical devices.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (Collateral Standard: EMC - Requirements and Tests, Edition 2:2001 with Amdts)	Passed	Ensures the device does not interfere with or is not affected by other electrical equipment.
Verification & Validation (V&V)	In accordance with international standards and FDA Guidance for process and design control	Passed	Confirms that the device meets design specifications and user needs.
Shelf Life	Included in V&V testing	Passed	Ensures device integrity over its intended storage period.
Environmental Control	Included in V&V testing	Passed	Confirms performance under various environmental conditions.
Shipping Effects	Included in V&V testing	Passed	Verifies that shipping does not compromise the device's safety or performance.
Performance (Force Application & Control)	Performance similar to predicates, or more uniform with less overall pressure	"Performed in a more uniform manner and with less overall pressure, allowing greater control than observed using a non-assisted approach."	This performance claim is central to justifying the "assist" function and demonstrating benefit over a purely manual injection.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of diagnostic or predictive AI. The testing described is performance testing for a hardware device.
- The "test data" referred to are from verification and validation (V&V) activities, including electrical, EMC, shelf life, environmental, and shipping tests, and demonstrations of force application.
- Provenance: This is not explicitly stated. Typically, such V&V testing would be conducted in a laboratory or engineering environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a hardware device. Ground truth, in the AI/SaMD sense, is not relevant here. The "ground truth" for the device's function is its ability to apply force in a controlled manner, which is evaluated through engineering and performance testing against specifications and standards, not through expert consensus on images or clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a hardware device. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic AI, neither of which applies here.
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 hardware device. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance for human readers, which is not relevant to this product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an assist device and inherently designed to be used with a human clinician. It is not an algorithm, and the concept of "standalone" performance for an algorithm doesn't apply. Its function is to aid the human in an existing task.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/SaMD sense. The "ground truth" for this device's performance is its adherence to engineering specifications, safety standards, and its ability to consistently apply force as measured by instruments. The claim of "more uniform manner and with less overall pressure, allowing greater control" would have been substantiated by measurable physical parameters (e.g., pressure sensors, force gauges, consistency metrics), rather than clinical outcomes or expert consensus on clinical data.
The sample size for the training set:
- Not applicable. This is a hardware device, not an AI/machine learning model. There is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Summary

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510(k) SUMMARY

AESTHETIC SCIENCES CORPORATION XPRESSE ASSIST DEVICE

Submitter/Sponsor's Name, Address, Telephone Number, Contact Person and Date Prepared:

Aesthetic Sciences Corporation 1455 Adams Drive Menlo Park, CA 94025 Main Phone: 650-322-9600 Facsimile: 650-322-9601 Contact Person: Denise F. Gottfried

JUN 30 2009

Date Prepared: April 10, 2009

Xpresse™ Assist Device Name of Device:

Common or Usual Name:	Piston Syringe (Syringe Assist, Syringe Accessory)Syringe Holder, Adaptor
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Classification Name

Classification:	Class II, Code FMF, 21 CFR 880.5860
Classification Name:	Syringe, Piston (Syringe Assist, Syringe Accessory)

Predicate Device

The XPRESSE Assist Device is substantially equivalent to the Carpuject® Cartridge Syringe Holder Accessory, K820164, and the iSecure Syringe Cartridge Holder, K063180, regarding indication for use, intended use, and operating principle.

The XPRESSE Assist Device does not raise new questions associated with safety and efficacy relative to indication for use, intended use, materials, and technology when compared to the predicate devices or other commercially available medical devices on the US Market. Technological differences between the predicate devices and the XPRESSE Assist Device have been determined to be acceptable in accordance with safety and performance testing results.

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Intended Use / Indications for Use

The XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.

Device Description

The XPRESSE Assist Device is a non-sterile, air/gas-powered device that is used to assist the The Ar RESSE risets rice the body. The clinician connects the XPRESSE Assist Device to the desired syringe, and uses the foot pedal to activate the XPRESSE Assist Device. When activated by ange, see Assist Device allows flow of compressed air/gas, which pushes the avringe plunger forward, dispensing the syringe contents. The XPRESSE Assist Device is compatible with standard glass or plastic barrel syringes.

The XPRESSE Assist Device includes the following components:

a controller to provide regulated, compressed air/gas to a syringe (syringe not a part of � this device),
a foot switch connecting to the control unit for clinician activation of the system, and �
a disposable adaptor and tubing unit, with integral plastic tube connecting the controller @ to the desired syringe.

Summary of Technological Characteristics Compared to Predicate Devices

The XPRESSE Assist Device as described in this submission is substantially equivalent to the predicate Carpuject® Syringe Holder Accessory and the iSecure Syringe Cartridge Holder with respect to the following characteristics:

All three devices are indicated for use in assisting the administration of sterile materials の
All three devices are intended to be used with prefilled piston syringes, as an accessory to g facilitate injection
All three devices which come in contact with the piston syringe use the same linear force � concept for pushing the piston syringe plunger forward, dispensing the contents of the piston syringe
All three devices are separate components to that of the prefilled piston syringe �

Both predicate devices comprise of a plunger rod with flanges or other surface area for the clinician to grasp. After the holder/accessory device is connected to the piston syringe (cartridge), the clinician applies pressure to the plunger rod which, in turn, applies pressure to the plunger stopper. This action dispels fluid from the piston syringe into the body.

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The XPRESSE Assist Device adaptor is used in the same manner as the predicate devices to The XI NESSE Assist Device adulties is assumer the predicates and the XPRESSE Assist Device is the source of force used to drive injection.

The XPRESSE Assist Device uses compressed air/gas as the force needed to apply pressure to the AI KEOSE Hosist Dovice asso scom the piston syringe into the body. Using a foot pedal to the punger stopper, diopening than clinician can decide when to begin and stop injection. When the air/gas flow path is open by depressing the foot pedal, regulated compressed air/gas is allowed to flow through the controller to the adaptor, which is connected to the prefilled piston syringe. The foot pedal is released to stop flow.

Note that the prefilled piston syringe is not provided with the XPRESSE Assist Device.

Either a pre-filled gas canister, or clinician-office supplied air/gas, which connects to the XPRESSE Assist Device controller unit may be used as the pressure source. The controller AI NESOL Assist Dovies contractor asi. Input pressure to the adaptor and syringe plunger is regulates the output pressure to 100psi by the clinician, who adjusts the pressure to the desired setting as viewed on the controller LED display.

Though the two predicate devices do not include an air/gas-powered feature, such technology is I hough the two productions been used to power other medical devices cleared via the pre-market went understood and has been are been are described in the XPRESSE Assist Device 510(k) submission.

Performance Testing

The XPRESS Assist Device has been evaluated for and has passed the criteria for safety and The XI KEOS Nober Device with applicable US FDA and internationally-recognized standards for electrical medical devices, including the following:

IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 (10/31/1995), and

IEC 60601-1-2, Medical Electrical Equipment - Part 1-2; General Requirements for Safety - Collateral IEC 00001-1-2, Medical Electrion Equipations and Tests (Edition 2:2001 with Amendment standard. Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)), (07/31/2008).

The XPRESSE Assist Device has also passed verification and validation (V&V) testing criteria The XI KESSE Assist Device not ass are process and design control procedures to support the safety m accordino with internation of the V testing for shelf life, environmental control and shipping affe meanced the or the product of the resign indicate that the XPRESSE Assist Device or the processintended and in accordance with industry standards and FDA Guidance.

Test data demonstrate substantial equivalency of the XPRESSE Assist Device in performance to the standard, non-assisted approach to injection. Typically, the XPRESSE Assist Device

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performed in a more uniform manner and with less overall pressure, allowing greater control than observed using a non-assisted approach.

Substantial Equivalence

The XPRESSE Assist Device is substantially equivalent to the Carpuject® Cartridge Syringe Holder Accessory, K820164, and the iSecure® Syringe Cartridge Holder, K063180. The XPRESSE Assist Device has the same indication for use and intended use as these predicates. The technological differences between the XPRESSE Assist Device and its predicate devices have been evaluated and data demonstrate that the XPRESSE Assist Device is safe for its intended use and performs as intended.

Summary

Based on the information provided in this notification, the subject device warrants the claim for substantial equivalence in accordance with Section 510(k) of the US Federal Food, Drug, and Cosmetic Act ("FDC Act").

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 30 2009

Aesthetic Sciences Corporation C/O Mr. Jeff D. Rongero Senior Project Engineer Underwriter Laboratories, Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina 27709

Re: K083583

Trade/Device Name: Xpresse Assist Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 15, 2009 Received: June 17, 2009

Dear Mr. Rongero:

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 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. Rongero

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Anthony O. anutan for

Susan Runner, D.D.S., M Acting 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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K083583

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Xpresse™ Assist Device

Indications for Use:

The XPRESSE Assist Device is a syringe assist device intended for use in the administration of sterile materials under aseptic conditions in accordance with the best judgment of the clinician.

Prescription Use _________________X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

Page __

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083583

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).