(17 days)
ID-300, K961309
Not Found
No
The description focuses on a mechanical, spring-loaded mechanism for injection and does not mention any computational or learning components.
No
The device is an auto-injector designed to assist in the injection of pharmaceutical products; it does not directly treat or prevent a disease, but rather facilitates the delivery of medication.
No
The device is an auto-injector for administering pharmaceutical products, not for diagnosing medical conditions.
No
The device description explicitly states it is made of "plastic molded parts and springs," indicating it is a physical hardware device, not software only.
Based on the provided information, the SOFTINJECT device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products. This involves administering substances into the body, not testing samples outside the body.
- Device Description: The description details a mechanical device (auto-injector) designed to facilitate injections. This aligns with a drug delivery or administration device, not a diagnostic test.
- 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. The SOFTINJECT's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
The SOFTINJECT is an auto-injector indicated for assisting in the subcutaneous or intracorpus cavernosa injection of approved pharmaceutical products with approved commercially available syringes and needles.
Product codes (comma separated list FDA assigned to the subject device)
KZH
Device Description
The SOFTINJECT is a syringe needle introducer, commonly known as an auto-injector. It is made of plastic molded parts and springs. The spring-loaded mechanism provides an injection with a hypodermic needle to a pre-determined depth below the skin surface. The SOFTINJECT is intended to be used with FDA-approved B-D 1 ml insulin syringes and approved needles filled with FDA-approved pharmaceutical products. The SOFTINJECT has been designed to assist in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous or intracorpus cavernosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
ID-300, K961309
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
§ 880.6920 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).
0
ကိုးကား
က JUN
510(k) Summary of Safety and Effectiveness as required by 21 CFR 807.92©
| 1. | Submitted by: | Androsystems srl
Via Alessandria, 25
00198 Rome, Italy |
|----|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact person: | Ms. Clara Lombardi
Managing Director
Telephone: (+39) 06 8842213
Facsimile: (+39) 06 8842286 |
| 3. | Date Summary
Prepared: | April 26, 1999 |
| 4. | Device Name: | Common or Usual Name: auto-injector
Proprietary and Trade Name: SOFTINJECT
Classification Name: Syringe needle introducer per
21 CFR 880.6920 |
| 5. | Predicate Device: | ID-300, 510(k) number K961309
Pos-T-Vac, Inc.
1701 N. 14th Ave.
PO Box 1436
Dodge City, KS 67801 |
Description of Device: 6.
The SOFTINJECT is a syringe needle introducer, commonly known as an auto-injector. It is made of plastic molded parts and springs. The spring-loaded mechanism provides an injection with a hypodermic needle to a pre-determined depth below the skin surface. The SOFTINJECT is intended to be used with FDA-approved B-D 1 ml insulin syringes and approved needles filled with FDA-approved pharmaceutical products. The SOFTINJECT has been designed to assist in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products.
7. Intended Use:
The SOFTINJECT is an auto-injector indicated for assisting in the subcutaneous or intracorpus cavernosa injection of approved pharmaceutical products with approved commercially available syringes and needles.
1
8. Comparison with Predicate Device
The SOFTINJECT is substantially equivalent to the Pos-T-Vac auto-injector, the ID-300, which was cleared by FDA on 10 June 1996 (K961309).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the left side of the image. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 1999
Dr. Ermanno Greco Marketing Director Androsystems srl Viale Liegi, 12 00198 Roma, Italy
Re : K991680 Trade Name: SOFTINJECT® Requlatory Class: II Product Code: KZH Dated: April 26, 1999 Received: May 17, 1999
Dear Dr. Greco:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Dr. Greco
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Direct or Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
SOFTINJECT Device Name:
Indications For Use:
The SOFTINJECT is an auto-injector used for the subcutaneous and intracorpus The SOF I INTECT is an auto injoctor proved pharmaceutical products with approved commercially available syringes and needles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patuccio Cucente
(Division Sign-Off)
Division of Digit-Off
Division of Dental, Infection Control, and General Hospital D 510/k) Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
SOFTINJECT 510(k)
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