(148 days)
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for use in intradermal injections of any substance or drug approved for intradermal delivery.
The MicronJet 600 Needle is a small plastic adapter (female luer) equipped with a chip having three microneedles designed to mate with any standard syringe (Luer Slip or Luer Lock). The MicronJet 600 is a sterile, single use device.
The NanoPass MicronJet 600 device is intended for injecting fluids into the body below the skin surface, specifically for intradermal injections of approved substances or drugs.
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes performance testing as demonstrating that the "MicronJet 600 is as safe and effective as the predicate devices."
Therefore, the implicit acceptance criteria are that the MicronJet 600 performs comparably to the predicate devices in terms of safety and effectiveness for intradermal injections.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety comparable to predicate devices | Performance testing demonstrated safety equivalent to predicate devices. |
| Effectiveness comparable to predicate devices | Performance testing demonstrated effectiveness equivalent to predicate devices. |
2. Sample Size and Data Provenance
The provided document does not specify the sample sizes used for the test set in either bench, animal, or clinical testing. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications
The document does not mention the use of experts to establish a ground truth for a test set, as this is a medical device approval and not an AI/diagnostic algorithm.
4. Adjudication Method
Not applicable, as this is related to medical device approval, not AI/diagnostic algorithm testing.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study is not relevant to its approval.
6. Standalone Performance
The "Performance Testing" section states that "Bench, animal and clinical testing was performed to assess the safety and effectiveness of the device for the stated indications for use." This indicates that the device undergoes standalone testing to demonstrate its performance independently.
7. Type of Ground Truth Used
The "ground truth" for this device would be established through:
- Bench Testing: Engineering measurements and physical properties (e.g., fluid delivery accuracy, needle integrity).
- Animal Testing: Physiological responses, tissue reactions, and successful delivery to the intended dermal layer.
- Clinical Testing: Human subject outcomes related to comfort, efficacy of fluid delivery, and absence of adverse events, demonstrating safe and effective intradermal injection.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this type of device.
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510(k) SUMMARY
NanoPass's MicronJet 600
FEB - 3 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
NanoPass Technologies Ltd. 3 Golda Meir St. Nes Ziona, 74036 Israel Tel: 972-(0)8-9313090 Fax: 972-(0)8-9313091
Contact Person:
Ofer Sharon, VP Medical Development 972-52-3335429 ofer@nanopass.com
Date Prepared: September 8, 2009
Name of Device and Name/Address of Sponsor
MicronJet 600
NanoPass Technologies Ltd. 3 Golda Meir St. Nes Ziona, Israel
Common or Usual Name
Microneedles Device
Classification Name
Hypodermic Single Lumen Needle, Product Code FMI, 21 C.F.R. § 880.5570
Piston Syringe, Product Code FMF, 21 C.F.R. § 880.5860
Device Trade Name:
MicronJet 600 Needle
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Predicate Devices
-
- Terumo Medical Corporation Terumo Allergy Syringe (K980796)
-
- BD Medical Surgical BD PrecisionGlide™ (K021475)
-
- Becton Dickinson SafetyGlide™ Syringe (K992734)
Intended Use / Indications for Use
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for use in intradermal injections of any substance or drug approved for intradermal delivery.
Technological Characteristics
The MicronJet 600 Needle is a small plastic adapter (female luer) equipped with a chip having three microneedles designed to mate with any standard syringe (Luer Slip or Luer Lock). The MicronJet 600 is a sterile, single use device.
Performance Testing
Bench, animal and clinical testing was performed to assess the safety and effectiveness of the device for the stated indications for use. Performance testing demonstrated that the MicornJet 600 is as safe and effective as the predicate devices.
Substantial Equivalence
The MicronJet 600 is substantially equivalent to its predicate devices (Terumo Allergy Syringe (K980796), BD Precisionglide™ hypodermic needle (K021475), and SafetyGlide™ Syringe (K0992734)). The MicronJet 600 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the MicronJet 600 and its predicate devices raise no new issues of safety or effectiveness. Performance data generated by the Company and detailed further in this notification, demonstrate that the MicronJet 600 is as safe and effective as its predicates for the stated indication. Thus, the MicronJet 600 is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nanopass Technologies, Limited C/O Mr. Jonathan Kahan Regulatory Counsel Hogan & Hartson LLP 555 13th Street NW Washington, District of Columbia 20004
Re: K092746
Trade/Device Name: MicronJet 600 Regulation Number: 21CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Il Product Code: FMI Dated: September 8, 2009 Received: September 8, 2009
Dear Mr. Kahan:
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. 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.
FEB - 3 2010
:
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Page 2 -Mr. Kahan
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 (OS) 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Chinton D. Avis
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): 14 (19 2 746
Device Name: MicronJet 600
Indications for Use:
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for intradermal injections of any substance or drug approved for this delivery route.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092746
14
\\DC - 028796/00001 - 2955294 v2
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).