The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Device Description

The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the insulin pressure to deliver preset basal profiles and patient programmed bolus of insulin through FDA cleared infusion sets into subcutaneous tissue. The ADI pump is restricted to sale by, or on the order of a physician.

AI/ML Overview

The provided document is a 510(k) summary for the NiliMedix ADI Insulin Pump, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the manner typically seen for novel devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding measured performance values. Instead, it states that the device was designed and tested in accordance with IEC 60601-2-24 and other relevant standards, and that performance tests showed the ADI's performance to be "substantially equivalent to the predicate device."

The types of tests conducted are listed, implying that the acceptance criteria would be derived from the requirements of the standards and the performance of the predicate device (Minimed Model 508, K990801).

Here's a conceptual representation based on the information, acknowledging that specific numerical criteria and results are not provided:

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Pump Flow rate Accuracy	Compliant with IEC 60601-2-24 and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Pump Bolus Accuracy	Compliant with IEC 60601-2-24 and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Battery Indication Performance	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Air In System Detection	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Valve leakage and Piston Leakage Alarm	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Valve blockage Alarm	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Cartridge depletion and Low insulin Alert	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Usability study	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Cartridge Performance validation	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Pump Operational Life validation	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Infusion set testing for compatibility	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Flow Rate Accuracy for Minimum Flow Rate	Compliant with IEC 60601-2-24 and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Flow Rate Accuracy after Change in infusion rate or Bolus Dose	Compliant with IEC 60601-2-24 and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Insulin Stability Study	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Spring Component validation	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Minimum Bolus Accuracy	Compliant with IEC 60601-2-24 and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Occlusion Alarm Test	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Free fall Test and Vibration tests	Compliant with relevant standards and equivalent to predicate device	ADI performance substantially equivalent to predicate device
Biocompatibility	Compliant with ISO 10993	Tested according to relevant standards
Sterilization validation	Compliant with relevant standards	Tested according to relevant standards
Electrical safety	Compliant with IEC 60601-1	Tested according to relevant standards
EMC	Compliant with IEC 60601-1-2, CISPR 11, IEC 61000-4-2/3/4/5, IEC 55011, IEC 801-2	Tested according to relevant standards

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

The document explicitly states that no animal or clinical studies were conducted for this 510(k) submission. All performance testing was non-clinical (bench testing). Therefore, there is no "test set" in the context of clinical data, sample size for patients, or data provenance from a specific country of origin (retrospective or prospective). The data provenance is entirely from laboratory bench testing performed by NiliMedix Ltd.

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

Not applicable. As no clinical studies were performed, there was no need for experts to establish ground truth from patient data. The ground truth for bench tests would be the established scientific and engineering principles, and the standards (e.g., IEC 60601-2-24) to which the device was tested.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication by experts was used.

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

Not applicable. This is not an AI/imaging device. It is an insulin pump. No MRMC studies were conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is an insulin pump, not an algorithm. The device's performance was evaluated inherently as a standalone product during bench testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical performance tests was based on:

Requirements outlined in specified international standards (e.g., IEC 60601-2-24, ISO 13485, ISO 10993, IEC 60601-1, IEC 60601-1-2, CISPR 11, IEC 61000-4-2/3/4/5, IEC 55011, IEC 801-2).
The performance characteristics of the legally marketed predicate device (Minimed Model 508). The submission's goal was to demonstrate that the ADI's performance was "as good as" the predicate device and met standard requirements.

8. The Sample Size for the Training Set

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

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

Not applicable, no training set was used.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Nilimedix. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the phrase "Innovative Medical" in a smaller font.

510(K) SUMMARY

510(k) Number K070844

JUN - 6 2008

Applicant's Name:	NiliMedix Ltd.Matam – Advanced Technology Center Building No. 5/2Haifa 31905ISRAELTel (972)4-855-0652Fax (972)4-850-0297
-------------------	----------------------------------------------------------------------------------------------------------------------------------------------

Yoram Levy, Osite Contact Person: 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 yoram@gsitemed.com
ADI Insulin Pump Trade Name:
Classification: Name: External infusion insulin pump Product Code: LZG Regulation No: 880.5725 Class: II Classification Panel: 80 - General Hospital and Personal Use Device

Device Description:

Intended Use Statement:

The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Predicate Device: Substantial equivalence to the following predicate device is claimed:

Minimed Model 508Comments of the program of the first and a first and a first of the Address of the Address of the Address of the Address of the Children		Ambulatory Insulin Pump K990801 Decision Date: June 8, 1999

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for "Nilimedix". The logo is in black and the font is bold. Below the logo, there is a tagline that says "Innovative Medicine".

Performance Standards

The performance standard that is applicable to the testing of infusion pumps is IEC60601-2-24.

The ADI complies with the European Mcdical Device Directive 93/42/EEC (Annex II) and with the voluntary standards ISO 13485, ISO 10993, IEC 60601-1, IEC 60601-1-2, CISPR 11, IEC 61000-4-2/3/4/5, IEC 55011 and IEC 801-2.

Summary of non-clinical performance data

The ADI Insulin Infusion Pump has been designed and tested in accordance with IEC 60601-2-24. The following tests were conducted:

Pump Flow rate Accuracy, Pump Bolus Accuracy, Battery Indication Performance, Air In System Detection, Valve leakage and Piston Leakage Alarm , Valve blockage Alarm, Cartridge depletion and Low insulin Alert, Usability study, Cartridge Performance validation, Pump Operational Life validation, Infusion set testing for compatibility with ADI insulin pump, Flow Rate Accuracy for Minimum Flow Rate, Flow Rate Accuracy after Change in the infusion rate or Bolus Dose, Insulin Stability Study, Spring Component validation, Minimum Bolus Accuracy, Occlusion Alarm Test, Free fall Test and Vibration tests.

The ADI pump was also tested for biocompatibility, sterilization validation, electrical safety and EMC according to the relevant standards.

Performance tests were conducted in order to show that the quality of the design is as good as the predicate device and meets the standard's requirements.

The performance tests show that the ADI performance is substantially equivalent to the predicate devicc

Summary of Clinical performance data

Due to the satisfactory results of the comprehensive bench performance tests, clinical study of predicate devices and the long use of predicate devices. NiliMedix believes that animal and clinical studies are not required to determine the safety and efficacy of the device.

Conclusions:

Evidence of equivalence has been demonstrated that:

· The NiliMedix ADI intended use and indications for use were previously cleared by FDA for the predicate device.
NiliMedix ADI Insulin Pump -- 510k Notification

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for "NiliMEDIX" in a bold, sans-serif font. Below the main logo, there is a smaller line of text that reads "Innovative Medical". The text is black and the background is white.

· Performance tests demonstrate that the ADI Insulin Pump is as safe and effective as the predicate for its intended use
· Safety and performance testing were implemented and found that the ADI Insulin Pump performs safe and effective.

Therefore, we believe that the ADI is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NiliMedix Limited C/O Mr. Yoram Levy Qsite 31 Haavoda Street Binyamina ISRAEL 30500

JUN - 6 2008

Re: K070844

Trade/Device Name: ADI Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: May 18, 2008 Received: May 23, 2008

Dear Mr. Levy:

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.

{4}------------------------------------------------

Page 2 - Mr. Levy

'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,

Signature

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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "Nilimedix" in a bold, sans-serif font. The letters are black and appear to be slightly pixelated. Below the word, there is a thin, horizontal line with some indistinct text or markings.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K070844

Device Name:

ADI

Indications for Use:

The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices 510(k) Number

Cinthia von

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

510(k) Number. K990844

1-6 NiliMedix ADI Insulin Pump - 510k Notification

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).