(198 days)
The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.
This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.
Target Population: Patients who have to be injected with liquid pharmaceuticals.
The INJEX™ and ROJEX™ Systems Extra are medical devices to apply liquid medicine needle-free through the skin into the subcutaneous tissue. The process is based on the generation of a defined high velocity jet of fluid to penetrate the skin and to transport the medicine to the subcutaneous tissue. The energy source to accelerate the fluid within the ampoule is an internal spring.
The INJEX™ Injector is designed for multi- use. To tense the spring within the small hand- held injector for injection the reset box is used. For patient's safety the injector is equipped with two safety mechanisms. The automatic mechanism will be deactivated by mounting the ampoule onto the injector, and before injecting
The ROJEX™ Injector is a disposable medical device for single- use. For patient's safety the injector is equipped with a manual safety mechanism, the safety ring. Before injecting the dose of medicine to the individual the safety ring needs to be shifted into the safe- off position.
To transfer the medicine from its different repositories into the ampoule several adapters are designed. In case, medicines in cartridges are used an aid is available: the transporter.
The INJEX™ Systems Extra consist of two main components which are re- usable:
- . INJEX™ Injector
- . Reset Box
The ROJEX™ Systems Extra represent the disposable medical device:
- · ROJEX™ Injector, pre- tensed
The three accessories for INJEX™ needle- free Injection systems Extra are:
- Transporter, re- usable .
- Adapter, sterile, usable for one medicine repository .
- Ampoule, sterile, for single- use .
The provided text describes a 510(k) premarket notification for the INJEX™/ROJEX™ Needle-free Injection System Extra. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the given information:
1. A table of acceptance criteria and the reported device performance:
- This information is not available in the provided text. The submission focuses on substantial equivalence rather than presenting specific performance acceptance criteria and corresponding test results.
2. Sample size used for the test set and the data provenance:
- This information is not available in the provided text. The document mentions non-clinical tests but does not specify a test set sample size or data provenance in the context of device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not available in the provided text. The submission does not describe a study involving expert-established ground truth for performance evaluation.
4. Adjudication method for the test set:
- This information is not available in the provided text.
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:
- This information is not available in the provided text. The device is a needle-free injection system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not available in the provided text. The device is a physical medical device, not an algorithm.
7. The type of ground truth used:
- This information is not available in the provided text in the context of device performance. The submission discusses "biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation" as part of non-clinical tests, which could be considered a form of ground truth for safety, but not for broader device performance as typically understood in the context of acceptance criteria.
8. The sample size for the training set:
- This information is not available in the provided text. The device does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established:
- This information is not available in the provided text. As above, this concept is not applicable to the device described.
Summary of available information regarding compliance/testing:
The submission states:
- "In addition to the supplier's raw material testing reqarding the ampoule, biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation were analysed."
- "The body contact of the ampoule is classified as short term (< 10 min) indirect contact (drug- mediated) to skin."
- "The investigation present that the INJEX ™ - and ROJEX™ needle-free injections systems Extra are safe and effective for the intended use and substantially equivalent to the legally market predicate devices."
This indicates that some non-clinical safety tests were performed, and the primary demonstration for market clearance was based on substantial equivalence to existing predicate devices (Hypex Jet Injector, Medi-Jector Choice, INJEX 50 System, Jet Syringe). The text doesn't describe a study with specific acceptance criteria that the device had to meet quantitatively beyond the general assessment of safety and effectiveness through equivalence.
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| 004 | PRE- MARKET NOTIFICATION | |||
|---|---|---|---|---|
| Dr. Zalewski05.09.2002 | 510(k) Summary(As required by 21 CFR 880.5430) | |||
| Page 1 / 1 | ||||
| A | Submitter Information | Rösch AG MedizintechnikBuckower Damm 114D - 12349 Berlin | K02078 | |
| Phone: 0049 (0)30 - 667 915-957Fax: 0049 (0)30-667 915-939Email: zalewski@roesch-ag.deContact: Dr.-Eng. Kerstin ZalewskiHead of Regulatory AffairsDate: July, 22nd, 2002 | SEP 2 5 2002 | |||
| B | Device InformationTrade/ Proprietary Name: | INJEX ™ needle- free injection system ExtraROJEX ™ needle- free injection system Extra | ||
| Common Name of device: | Jet Injector | |||
| Classification Name: | Fluid Injector, non- electrically powered | |||
| C | Predicate Device(s): | Hypex Jet Injector, Medi-Jector Choice, INJEX 50 System,Jet Syringe | ||
| Predicate 510(k) #: | K945873; K962956, K003864, K003741 | |||
| D | Device Description: | The INJEX™ and ROJEX™ Systems Extra are medical devices to apply liquid medicine needle-free throughthe skin into the subcutaneous tissue. The process is based on the generation of a defined high velocity jetof fluid to penetrate the skin and to transport the medicine to the subcutaneous tissue. The energy source toaccelerate the fluid within the ampoule is an internal spring.The INJEX™ Injector is designed for multi- use. To tense the spring within the small hand- held injector forinjection the reset box is used. For patient's safety the injector is equipped with two safety mechanisms. Theautomatic mechanism will be deactivated by mounting the ampoule onto the injector, and before injecting |
The ROJEX™ Injector is a disposable medical device for single- use. For patient's safety the injector is equipped with a manual safety mechanism, the safety ring. Before injecting the dose of medicine to the individual the safety ring needs to be shifted into the safe- off position.
To transfer the medicine from its different repositories into the ampoule several adapters are designed. In case, medicines in cartridges are used an aid is available: the transporter.
The INJEX™ Systems Extra consist of two main components which are re- usable:
- . INJEX™ Injector
- . Reset Box
The ROJEX™ Systems Extra represent the disposable medical device:
- · ROJEX™ Injector, pre- tensed
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| 004 | |
|---|---|
| Dr. Zalewski | |
| 05.09.2002 |
| PRE- MARKET NOTIFICATION | |
|---|---|
| 510(k) Summary | |
| (As required by 21 CFR 880.5430) |
RÖSCH
Rösch AG MedizintechnikPage 2 / 2
The three accessories for INJEX™ needle- free Injection systems Extra are:
- Transporter, re- usable .
- Adapter, sterile, usable for one medicine repository .
- Ampoule, sterile, for single- use .
- E Intended Use:
The INJEX™ - and ROJEX™ needle- free injection systems Extra are designed for the delivery of medicines which are administrated subcutaneously by jet injection. Because of the absence of a needle, the fluid is transferred from an ampoule via its mirco- orifice through the aid of a capillary, high velocity, to the body.
F Comparison of Required Technological Characteristics: The INJEX™ - and ROJEX™ needle-free injection systems Extra picture the same technological characteristics as the predicated devices. The key difference of the ROJEX™ injector is its mainly plastic composition and single- use mode. Both devices, INJEX™ - and ROJEX™ injectors, are suitable to deliver liquid pharmaceuticals into the subcutaneous tissue of the body. Due to the technological identity and the same indications for use, no additional safety items had to be investigated.
- G Summary and Conclusions of non- clinical Tests
In addition to the supplier's raw material testing reqarding the ampoule, biological effects as cytotoxicity, tissue irritation, systemic toxicity, and sensitisation were analysed.
The body contact of the ampoule is classified as short term (< 10 min) indirect contact (drug- mediated) to skin.
Conclusion
The investigation present that the INJEX ™ - and ROJEX™ needle-free injections systems Extra are safe and effective for the intended use and substantially equivalent to the legally market predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2002
Mr. Mark Job Responsible Third Party TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K020786
Trade/Device Name: INJEX™/ROJEX ™ Needle-free Injection System Extra Regulation Number: 880.5430 Regulation Name: Non-electrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: September 9, 2002 Received: September 10, 2002
Dear Mr. Job:
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.
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.
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Page 2 - Mr. Job
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski 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
Verl 3 - 4/24/96
Applicant: Rösch AG Medizintechnik, Buckower Damm 114, 12349 Berlin, Germany
510(k) Number (if known): _
Device Name: INJEX ™/ ROJEX ™ Needle- free Injection System Extra
Indications For Use:
The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.
This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.
Target Population: Patients who have to be injected with liquid pharmaceuticals.
Patricia Cuceniti
510(k) Number: K020786
Prescription Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).