(198 days)
No
The description focuses on the mechanical aspects of a needle-free injection system and does not mention any AI or ML components.
No
The device delivers medication, but it does not inherently treat diseases or conditions itself. Its function is to facilitate the injection of therapeutic drugs.
No
The device is designed to deliver medicine subcutaneously via jet injection, not to diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including injectors, a reset box, adapters, a transporter, and ampoules. The device's function is based on a physical mechanism (spring tension) to deliver medication.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver medicines that can be administrated subcutaneously by jet injection." This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description focuses on the mechanism of delivering liquid medicine into the subcutaneous tissue. It describes injectors, ampoules, and adapters for transferring medicine. None of these components are related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly described as a system for administering medication, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
KZE
Device Description
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 .
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
Prescription Use (Per 21 CFR 801.109) and to sale by or on the order of a physician.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (
§ 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).
0
| 004 | PRE- MARKET NOTIFICATION | |||
|---|---|---|---|---|
| Dr. Zalewski | ||||
| 05.09.2002 | 510(k) Summary | |||
| (As required by 21 CFR 880.5430) | ||||
| Page 1 / 1 | ||||
| A | Submitter Information | Rösch AG Medizintechnik | ||
| Buckower Damm 114 | ||||
| D - 12349 Berlin | K02078 | |||
| Phone: 0049 (0)30 - 667 915-957 | ||||
| Fax: 0049 (0)30-667 915-939 | ||||
| Email: zalewski@roesch-ag.de | ||||
| Contact: Dr.-Eng. Kerstin Zalewski | ||||
| Head of Regulatory Affairs | ||||
| Date: July, 22nd, 2002 | SEP 2 5 2002 | |||
| B | Device Information | |||
| Trade/ Proprietary Name: | INJEX ™ needle- free injection system Extra | |||
| ROJEX ™ 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 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
1
| 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 (