(97 days)
The Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) is an automatic injection device with a cooling mechanism for injection and needle withdrawal.
The Modified Easy-Ject Automatic Injector is a hand held device that performs automates a disk shaped cooling element that cools the skin prior to the needle injection. The Modified Easy-Ject Automatic Injector Device is an automatic injection device with a cooling mechanism for injection and needle withdrawal.
The provided text is a 510(k) summary for the EZ-JECT Automatic Injector Device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.
The document is purely a regulatory submission, focusing on establishing substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a document that includes:
- A section explicitly defining acceptance criteria (e.g., "The device must achieve X performance metric with Y confidence").
- A study report detailing the methodology, results, and conclusions regarding those acceptance criteria.
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510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
- MedicSense, Ltd. Submitter 1. (a) 14 Imber St. Address: Kiriat Arie Petah Tikva, Israel 49511 www.medicsense.com Manufacturer indolor Ltd. 1. (b) 429 Hamered St. Address: POB 50114 Tel Aviv, Israel 61500 972-3-510-8801 Mfa. Phone: Uri Erez, Product Manager Contact Person: June 19, 2005 Date: Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) Device Name 2. Syringe Needle Introducer, Class 2, Product Code 80KZH, & Classification 21 CFR 880.6920 Name: Easy-Ject Automatic Injector Device K972383 Predicate Devices: 3. The Modified Easy-Ject Automatic Injector is a hand held device that Description: 4. The Modified Edoy Coochutaneous needle injection and retraction. The performs automates a disk shaped cooling element that cools the skin prior to the needle injection. The Modified Easy-Ject Automatic Injector Device is an automatic injection Intended Use: 5. I ne woulfha cooling mechanism for injection and needle withdrawal. With respect to technology, the Modified Easy-Ject Automatic Injector Comparison of 6. With respect to toomlelegy, I hent to its predicate device, the Easy-Ject. The Technological major differences are the size, ergonomics, and the ability to operate with Characteristics: major diffications are the size, caye not changed the safety or efficacy of the device.
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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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.
Public Health Service
SEP 27 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Indolor, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, Limited 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K051667
Trade/Device Name: EZ-JECT Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Inducer Regulatory Class: II Product Code: KZH Dated: June 19, 205 Received: July 8, 2005
Dear Mr. Hattub:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Scellon 31 (t).) profits is substantially equivalent (for the referenced above and have determined the treatly marketed predicate devices marketed in
indications for use stated in the enclosure and estables of the Mical Device indications for use stated in the chelosares to regalized and of the Medical Device interstate commerce prior to way 20, 1770, the enaver with the provisions of
Amendments, or to devices that have been reclassified in accordance annrovel of a premarket Amendments, of to devices that have been recurse approval of a prematket the Federal Food, Drug, and Cosmetic Act (rice, market the device, subject to the general approval application (1 MA). Tou may, may and controls provisions of the Act include controls provisions of the Act. The genices, good manufacturing practice, requirements for anilual reagainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n affect If your device is classified (sec above)into controls. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Title 21 Parts 800 to 898 (PMA), it may be subject to such additional controls. Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, Rederal your device can be found in the Code of Peacharts, which in the Federal Register
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Page 2 – Mr. Hattub
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ issuance of a substant is as a lies with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decemination that 70at and inistered by other Federal agencies.
of the Act or any Federal statutes and regulations administration no: pensitration of the Act of any rederal statutes and reginations, but not limited to: registration
You must comply with all the Act's requirements, including of monument You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFK Part 607), labeling (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Pat 820); and if requirements as set form in the quality systems (QS) regions = (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-54 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 a This letter will anow you to begin malicoming your artist couvalence of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, new premarket notification. The FDA midnig of substantial equivals 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), If you desire specific advice for your device on our career of your and the regulation please contact the Office of Complanes at (210) = reference (21CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification that from the entified, "Misbranding by received to promation on your responsibilities under the Act from the may obtain other general miorination on your responser Assistance at its toll-free DIVIsion of Sinan 3041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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):
Device Name: Modified Easy-Ject Automatic Injector Device
Indications For Use: The Modified Easy-Ject Automatic Injector Device (also known as Indications For Use: The Modified Easy-Ject Automatic Mjoctor Books ( needle withdrawal.
Prescription Use 区 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Cintan V, ampton
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospealised 7-17-05 Infection Control, Dental Devices
510(k) Number. K954667
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§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).