(17 days)
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.
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.
This document is a 510(k) summary for the SOFTINJECT auto-injector, a device designed to assist in the subcutaneous or intracorpus cavernosa injection of pharmaceutical products. It compares the SOFTINJECT to a predicate device, the ID-300 auto-injector.
Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of acceptance criteria or specific reported device performance metrics. The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance testing with accept/reject criteria.
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify a sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The submission is a regulatory document seeking market clearance based on substantial equivalence to an existing device, not a clinical study report with detailed methodology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The provided text does not mention any experts used to establish ground truth or their qualifications. This type of information would typically be found in a clinical or performance study report, which is not included here.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Furthermore, the SOFTINJECT is a mechanical auto-injector, not an AI-powered diagnostic or assistive technology for human readers. Therefore, this type of study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The provided text does not mention any standalone performance testing for an algorithm. As stated above, the device is a mechanical auto-injector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The provided text does not describe the type of ground truth used. This suggests that formal ground truth establishment, as would be done for a diagnostic device or AI, was not the primary focus of this 510(k) submission. The equivalence is based on device design and intended use.
8. The sample size for the training set
The provided text does not mention a training set sample size. This is not an AI/machine learning device, so the concept of a training set is not applicable.
9. How the ground truth for the training set was established
The provided text does not mention how ground truth for a training set was established. Again, this is not an AI/machine learning device.
Summary of what the document does provide:
The document is a 510(k) Pre-Market Notification for a medical device (auto-injector). Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (ID-300, K961309).
- Acceptance Criteria & Performance: The document implies that the "acceptance criteria" for clearance was the demonstration of substantial equivalence to the predicate device in terms of design, intended use, and functioning (providing an injection to a pre-determined depth). Specific quantitative performance data against defined acceptance criteria are not provided in this summary.
- Study: The "study" here is essentially the comparison of the SOFTINJECT to the predicate device, the ID-300 auto-injector. This comparison would have likely involved engineering analysis, design documentation review, and perhaps some internal functional testing to confirm the mechanical operation, but the details of such tests are not included in this 510(k) summary. The FDA's letter indicates that the device was reviewed for its "clinical indications for use" and determined to be substantially equivalent.
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က JUN
510(k) Summary of Safety and Effectiveness as required by 21 CFR 807.92©
| 1. | Submitted by: | Androsystems srlVia Alessandria, 2500198 Rome, Italy |
|---|---|---|
| 2. | Contact person: | Ms. Clara LombardiManaging DirectorTelephone: (+39) 06 8842213Facsimile: (+39) 06 8842286 |
| 3. | Date SummaryPrepared: | April 26, 1999 |
| 4. | Device Name: | Common or Usual Name: auto-injectorProprietary and Trade Name: SOFTINJECTClassification Name: Syringe needle introducer per21 CFR 880.6920 |
| 5. | Predicate Device: | ID-300, 510(k) number K961309Pos-T-Vac, Inc.1701 N. 14th Ave.PO Box 1436Dodge 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.
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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).
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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.
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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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§ 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).