(42 days)
Not Found
No
The description focuses on mechanical and hydraulic components and does not mention any AI/ML terms or functionalities.
Yes
The device is described as "indicated for the delivery of vaccines or medications to the subcutaneous tissue," which clearly defines it as a therapeutic device designed to administer treatments.
No
Explanation: The device is described as a "needle-free fluid injector system" for "delivery of vaccines or medications." It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines physical hardware components: a hand-held injector unit, a spring-powered mechanism, a hydraulic fluid power source, and a foot pump. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of vaccines or medications into the subcutaneous tissue. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description details a system for injecting fluids, not for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for administering substances to a patient.
N/A
Intended Use / Indications for Use
The needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. The device is to be used by a health care professional only.
Product codes (comma separated list FDA assigned to the subject device)
KZE
Device Description
The Human Subcutaneous Injector system consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.
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
health care professional
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)
The performance characteristics are substantially equivalent to the Bi-3M according to test protocols conducted for dosage accuracy, penetration, force, focus, sound, and stream quality. Safety tests performed for contamination were successful.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 2 4 2004
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VIII. Special 510-(k) Summary
The summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
Submitter Information:
Regulatory/Clinical Consultants, Inc. 200 NE Mulberry, Suite 200 Lees Summit, MO 64086
Contact Person: Jim Stanley
Phone: 816-347-9224
Date Prepared: May 11, 2004
Device Information:
Proprietary Name: Human Subcutaneous Injector system
Common Name: Needle-free fluid injection system
Classification Name: Nonelectrically powered fluid injector
Predicate Devices:
| K013256 | Felton International's Bi-3M |
|---|---|
| Preamendment | Ped-O-Jet |
Device Description: The Human Subcutaneous Injector system consists of a hand-held injector unit to which a multiple-dose vial of vaccine or medication can be attached. The unit is spring-powered and is connected to its hydraulic fluid power source, which is operated by a foot pump.
Intended Use: The needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. The device is to be used by a health care professional only.
Summary: The performance characteristics are substantially equivalent to the Bi-3M according to test protocols conducted for dosage accuracy, penetration, force, focus, sound, and stream quality. Safety tests performed for contamination were successful.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2004
Felton International, Incorporated C/O Mr. James E. Stanley Associate Director of Quality Assurance Regulatory/Clinical Consultants, Incorporated 200 NE Mulberry, Suite 200 Lee's Summit, Missouri 64086
Re: K041280
Trade/Device Name: Human Subcutaneous Injector System HSI 500 Regulation Number: 880.5430 Regulation Name: Nonelectrically Powdered Fluid Injector Regulatory Class: II Product Code: KZE Dated: June 10, 2004 Received: June 15, 2004
Dear Mr. Stanley:
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 approvisions 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 (1 wr ), it inch obe of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -Mr. Stanley
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that ITDA $ Issualles of a bacause complies with other requirements
mean that FDA has made a determination that your device there Federal egencies mean that FDA has made a decemination hate Jour ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by pot limited to regist of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including massise You must comply with an the Act 3 requirements intelles intelling practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laocing (21 CFR (05) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a requirements as set form in the quality systems (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 5 10(k) This letter will anow you to begin maneting your and equivalence of your device to a premarket nothleation. THC I DA miding of cassification 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), If you desire specific advice to: your de at (301) 594-4618. Also, please note the regulation prease contact inc Office or Comphanes an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general mironma.let en en the mational and Consumer Assistance at its toll-free Division of Simall - 2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Lin, Ph.D.
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 (if known): K041280
Device Name: Human Subcutaneous Injector System HSI 500
Indications For Use: This needle-free fluid injector system is indicated for the delivery
f the skin the start start of the descriptions we tinsue by poperrating the skin un Indications For Use: This neede-ree-num nicolor eyeten to me of vaccines of medications to the Suboutanovas assure of the subscription only.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Sam Moreau for ADEC
6/24/04
nesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041280
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