SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 by SPECTRX, INC.

The intended use of the SimpleChoice reservoir Pro is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

Device Description

The SimpleChoice reservoir Pro (3.0mL), Reference Number RP-30, is a single use reservoir system used to deliver medications subcutaneously. The user fills the reservoir via a standard hypodernic needle provided with the device. The 3.0 ml reservoir Pro then attaches to an SimpleChoice infusion set having a female luer lock with a retainer feature, and is placed in an external infusion pump. If the reservoir will be used with a Paradigm pump the plunger rod is detached and the reservoir is secured with the retainer feature.

AI/ML Overview

This 510(k) summary describes a device modification rather than a new device, and as such, the study conducted focused on demonstrating equivalence to the predicate device. Therefore, the information provided within the document does not contain all the details typically found in studies for novel devices, especially concerning detailed acceptance criteria and standalone performance metrics.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The new device is as safe, as effective, and performs the same as the original device, the SimpleChoice reservoir." and "The tests performed show such equivalence."

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Safety	Equivalent to predicate device	"as safe" as the original device
Effectiveness	Equivalent to predicate device	"as effective" as the original device
Performance	Performs the same as predicate device	"performs the same as the original device"
Technological Characteristics	No significant difference from predicate device	"no difference in technological characteristics"
Issues of Safety or Effectiveness	No new significant issues	"no new significant issues of safety or effectiveness"

Study Details:

The provided document is a 510(k) summary for a device modification (SimpleChoice reservoir Pro) to an already legally marketed device (SimpleChoice reservoir). The entire premise of this submission is to demonstrate substantial equivalence to the predicate device, not to establish novel performance against specific quantitative criteria.

The summary states: "The modifications which are the subjects of this premarket notification have no untoward effect on the safety and effectiveness of the device." and "The tests performed show such equivalence." However, it does not detail the specific tests conducted, their methodologies, or the raw results (e.g., specific leakage rates, flow accuracy, material strength tests) that led to this conclusion. The focus is on the administrative aspects of obtaining 510(k) clearance based on equivalence.

Therefore, many of the requested details about the study cannot be extracted from this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in the provided document. The summary only mentions "tests performed."
Data Provenance: Not specified. Given it's a device modification and likely bench testing, it would generally be considered prospective testing conducted by the manufacturer, but country of origin or specific lab is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is not applicable to this type of 510(k) submission. For a device modification seeking substantial equivalence, the "ground truth" is typically established by comparing the modified device's performance against the known and acceptable performance of the predicate device through engineering tests, rather than expert interpretation of medical data.
No experts (e.g., radiologists) would be used in this context to establish a "ground truth" in the way one might for diagnostic AI.

4. Adjudication Method for the Test Set:

Not applicable. This type of submission relies on objective engineering and performance testing, not subjective adjudication of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is explicitly not an MRMC study. MRMC studies are typically for diagnostic imaging devices or algorithms where human readers' performance is being evaluated or compared, often with and without AI assistance. This device is an infusion reservoir.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Not applicable in the typical sense. A standalone study, as usually understood in the context of AI, refers to the algorithm's performance independent of human input. This device is a mechanical component of an infusion system.
However, if interpreted as "bench testing of the device itself without human intervention affecting its inherent function," then the undisclosed "tests performed" would likely fall into this category (e.g., pressure tests, flow rate consistency, material compatibility). The document does not provide details of these tests.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and performance of the predicate device. The tests (though not detailed) would have aimed to demonstrate that the modified device's performance metrics are equivalent to or better than those of the predicate. This is based on engineering specifications and established performance characteristics of the original SimpleChoice reservoir, rather than pathology, expert consensus, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, this is not an AI/machine learning device.

Summary

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Ko51045

AUG 2 - 2005

SIMPLECHOICE

A SpectRx, Inc. Company CORPORATE OFFICE 4955 Avalon Ridge Parkway * Suite 300 Norcross, GA 30071 Telephone: (770) 242-8723 Fax: (770) 242-8639

510(k) Summary

Date Submitted: July 14, 2005

In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, a 510(k) Summary follows for a Device Modification:

Submitter: SpectRx Inc (d/b/a SimpleChoice), 4955 Avalon Ridge Parkway, Suite 300, Norcross, GA 30071

Contact: William M Vondersmith (770) 242-8723 ext 282

Name of Device: SimpleChoice reservoir Pro Reference Number RP-30

Modified Device: Sterling Medivations Simplicity Infusion Reservoir 510(k) K013767, Marketed as SimpleChoice reservoir Reference Number R-30

Description of Device: The SimpleChoice reservoir Pro (3.0mL), Reference Number RP-30, is a single use reservoir system used to deliver medications subcutaneously. The user fills the reservoir via a standard hypodernic needle provided with the device. The 3.0 ml reservoir Pro then attaches to an SimpleChoice infusion set having a female luer lock with a retainer feature, and is placed in an external infusion pump. If the reservoir will be used with a Paradigm pump the plunger rod is detached and the reservoir is secured with the retainer feature.

The modifications which are the subjects of this premarket notification have no untoward effect on the safety and effectiveness of the device.

Intended Use of the Device: The intended use of the SimpleChoice reservoir Pro is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

Comparison of the Technology Features of the Modified Device: The SimpleChoice reservoir Pro modified device design of the SimpleChoice reservoir, a legally marketed device. They differ slightly in filling mechanism, i.e., ability to detach the plunger rod and retain in the Medtronic MiniMed Paradigm numps. The new device is as safe, as effective, and performs the same as the original device, the SimpleChoice reservoir.

Summary and Conclusion of Non-clinical and Clinical Tests:

The intended use of the SimpleChoice reservoir Pro is identical to that of the SimpleChoice reservoir, the original device. There is no difference in technological characteristics and there are no new significant issues of safety or effectiveness. The tests performed show such equivalence.

William M. Vondersmith Quality Assurance/Regulatory Affairs Manager SpectRx Inc /SimpleChoice

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 - 2005

Spectrx, Incorporated c/o Mr. William M. Vondersmith 4955 Avalon Ridge Parkway, Suite 300 Norcross, Georgia 30071

Re: K051045

Trade/Device Name: SimpleChoice 3.0 ML Reservoir Pro Reference Number RP-30 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN Dated: July 14, 2005 Received: July 15, 2005

Dear Mr. Vondersmith:

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. Vondersmith

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris Linn, Ph.D.

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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Indications for Use

510(k) Number (if known): K051045

Device Name:_SimpleChoice reservoir Pro

Indications For Use:

Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quy

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K081065

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).