← Product Code [KZH](/productcode/KZH) · K991680 # SOFTINJECT (K991680) _Androsystems Srl · KZH · Jun 3, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K991680 ## Device Facts - **Applicant:** Androsystems Srl - **Product Code:** [KZH](/productcode/KZH.md) - **Decision Date:** Jun 3, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6920 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## 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. ## Device Story SOFTINJECT is a spring-loaded auto-injector designed to assist in the administration of pharmaceutical products. The device is constructed from plastic molded parts and springs. It operates by housing an FDA-approved 1 ml insulin syringe and needle, utilizing a spring-loaded mechanism to deliver the injection to a pre-determined depth below the skin surface. The device is intended for use with approved pharmaceutical products. It is designed to facilitate the injection process for the user, ensuring consistent delivery depth. The device is intended for use in clinical or home settings to assist patients or clinicians in administering subcutaneous or intracorpus cavernosa injections. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Plastic molded housing with internal spring-loaded mechanism. Dimensions/form factor designed to accommodate standard 1 ml insulin syringes. Manual operation via spring release. No electronic components, software, or connectivity. ## Regulatory 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. ## Predicate Devices - ID-300 ([K961309](/device/K961309.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 {4}------------------------------------------------ 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) Page 9 of 22 --- **Source:** [https://fda-staging.innolitics.com/device/K991680](https://fda-staging.innolitics.com/device/K991680) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com