(26 days)
Not Found
No
The description focuses on a mechanical, non-electrical device for fluid delivery and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as an injection system to deliver fluid, not to treat a condition or disease.
No
This device is an injection system designed to deliver fluid subcutaneously, not to diagnose a condition.
No
The device description clearly states it is a "needle-free injection system" and a "nonelectrically powered device" that delivers fluid via a "high velocity jet," indicating it is a physical hardware device.
Based on the provided information, the Mini-Ject device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Mini-Ject Function: The Mini-Ject device is designed to deliver fluid subcutaneously into the body. It is an injection system, not a device that analyzes samples taken from the body.
The description clearly states its purpose is to administer injections, which is an in-vivo (within the living body) procedure, not an in-vitro (in glass/outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.
Product codes
KZE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.
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)
No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
5. Summary of Safety and Effectiveness
Scott Huie Submitted By: Vice President of Operations Biovalve Technologies, Inc
21 July, 2005 Date Prepared:
| 5.1. Trade/Proprietary Name: | Biovalve Mini-Ject Needlefree Injection Systems |
|---|---|
| 5.2. Common/Usual Name: | Needlefree Injector; Jet Injector |
- Non-Electrically Powered Fluid Injector 5.3. Classification Name:
5.4. Classification:
FDA has classified Non-Electrically Powered Fluid Injector Jet Injectors in Class II. Final Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel
KZE- Non-Electrically Powered Fluid Injector Jet Panel: 80 Procode: Injectors
-
5.5. Purpose of Submission
To update the Instructions for Use for the currently marketed Needlefree Iniector in order to clarify and simplify the warnings, precautions and contraindications sections. -
5.6. Substantial Equivalence
The product with the modified Instructions for Use is substantially equivalent to the currently marketed product. -
5.7. Technological Characteristics
This is a label only modification and as a result it does not change the technological characteristics of the current product. -
5.8. Performance Data
No change was made to the Mini-Ject device and therefore no physical testing was required to confirm the injectors meet their specifications. -
5.9. Conclusion
BioValve, Inc. concludes based on the information presented that the modified product (i.e. modified Instruction for Use) is substantially equivalent to the current product legally marketed in the USA.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 2005
Mr. Scott Huie Vice President of Operations BioValve Technologies, Incorporated 155 Flanders Road Westborough, Massachusetts 01581
Re: K051985
K021969
Trade/Device Name: BioValve Mini-Ject Needlefree Injection System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically powered fluid injector Regulatory Class: II Product Code: KZE Dated: July 21, 2005 Received: July 25, 2005
Dear Mr. Huie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars annent date of the Medical Device Amendments, or to commerce provided 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). and Cosmetic Act (71ct) that do nov sequent to the general controls provisions of the Act. The You may, therefore, market the devices, octorements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (soc aborb) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controlier and one of the 21, Parts 800 to 898. In addition, FDA may be found in the Outs of concerning your device in the Federal Register.
2
Page 2 - Mr. Huie
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a builter complies with other requirements of the Act
that FDA has made a determination that your device complies with on your must that FDA has made a decemmation administered by other Federal agencies. You must or any Federal Statures and regulations daministered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: ret comply with an the Act s requirements, merading, and manufacturing practice requirements as set CFR Part 807), labening (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (QD) regardens (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decreens over device as described in your Section 510(k) I his letter will anow you to begin marketing your artial equivalence of your device to a legally premarket notification. The PDF mailing of basistication 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 If you desire specific advice ion your ac not the same and the regulation entitled, and contact the Office of Complanes at (210) = i C = a rt 807.97). You may obtain "Misbranding by reference to promanto notified in the Act from the Division of Small
other general information on your responsibilities under the Act from the 2000 C28.00 other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consultation of Consultant Constitutions try/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
3
INDICATIONS FOR USE
510(k) Number: K051985
MINI-JECT NEEDLEFREE INJECTIO BIOVALVE Device Name: SYSTEM
Indications for Use:
The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
✓
or
Over-the-Counter Use:
(Per 21 CFR 801.109)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Infection October Deman Dayloes
| 510(k) No. | K945195 |
|---|---|
| ------------ | --------- |