(437 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on traditional pump mechanisms and safety features.
Yes.
The device is intended for the continuous delivery of insulin for the management of diabetes mellitus, which is a therapeutic purpose.
No
This device is an insulin pump, which is a therapeutic device designed for continuous delivery of insulin, not for diagnosing a condition.
No
The device description explicitly states it is a "battery operated, rate programmable micro infusion pump" with a "custom reservoir" and "piston," indicating it is a hardware device that delivers insulin.
Based on the provided information, the NiliMedix ADI insulin pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the continuous delivery of insulin for the management of diabetes. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description clearly states it's a pump designed for delivering insulin into subcutaneous tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NiliMedix ADI insulin pump's function is to administer a substance (insulin) to treat a condition, which falls under the category of a therapeutic device.
N/A
Intended Use / 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.
Product codes
LZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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
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. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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510(K) SUMMARY
510(k) Number K070844
JUN - 6 2008
| Applicant's Name: | NiliMedix Ltd.
Matam – Advanced Technology Center Building No. 5/2
Haifa 31905
ISRAEL
Tel (972)4-855-0652
Fax (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:
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.
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 508
| Comments 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 |
|---|
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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
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- · 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.
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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.
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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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
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