(144 days)
The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.
The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body.
The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
The provided text describes the acceptance criteria and a study for the DAI-R™ Autoinjector.
1. Table of Acceptance Criteria and Reported Device Performance
The device was assessed using sections and methods specified in ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods."
| Acceptance Criteria (from ISO 11608:2000) | Reported Device Performance |
|---|---|
| Activation force | Met requirements |
| Needle extension | Met requirements |
| Injection time | Met requirements |
| Completeness of injection | Met requirements |
| Functionality | Met requirements |
| Robustness | Met requirements |
2. Sample Size and Data Provenance
The provided document does not specify the exact sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the DAI-R met the requirements of ISO 11608:2000.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable and not provided in the document. The device is a mechanical autoinjector, and its performance evaluation against ISO standards typically involves engineering and functional testing rather than expert-established ground truth in a clinical or diagnostic sense.
4. Adjudication Method
This information is not applicable and not provided. Performance against an ISO standard for a mechanical device does not typically involve an adjudication method in the way medical imaging or clinical studies do.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable and was not done for this type of mechanical device.
6. Standalone (Algorithm Only) Performance
No. This concept is not applicable to a mechanical autoinjector. The performance described is inherently "standalone" in a functional sense, as it refers to the device's ability to meet its operational specifications.
7. Type of Ground Truth Used
The "ground truth" for evaluating the DAI-R's performance was the requirements and specifications identified in ISO 11608:2000. This standard sets objective, measurable criteria for pen injectors.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. Mechanical devices are typically developed and validated through engineering design, testing, and adherence to standards, not through "training sets" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. The development and validation process for this mechanical device would not involve establishing ground truth for a training set in the way AI models are trained.
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Image /page/0/Picture/0 description: The image shows the logo for SHL Medical. The logo consists of a stylized graphic to the left of the text "SHL MEDICAL". The graphic is a black shape that resembles a stylized medical symbol. The text is in a bold, sans-serif font.
Kobo 141
רייני ביינונג
510(k) SUMMARY
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- Submitter
JUN 1 2 2006
- Submitter
SHL Medical, USA 23 Vreeland Road, Suite 104 Florham Park, New Jersey 07932 Office Telephone: 973 822-3007
Contact Person Lucio Giambattista Telephone: 973 822-3007
Date of Preparation: January 18, 2006
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- Device Information
Device Trade Name: DAI-RTM Device Common Name: Auto-injector Classification Name: Syringe Needle Introducer
- Device Information
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- Device to which substantial equivalence is claimed
Device Name: SHL Medical, USA Disposable Autoinjector "DAI" 510(k) Clearance Number: K050434 Device Common Name: Syringe needle introducer Classification Name: Syringe Needle Introducer
- Device to which substantial equivalence is claimed
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- Device Description
The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body.
- Device Description
The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
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Image /page/1/Picture/0 description: The image shows the logo for SHL Medical. The logo consists of the text "SHL MEDICAL" in a bold, sans-serif font. To the left of the text is a stylized graphic element that appears to be a combination of lines and shapes, possibly representing a medical device or a stylized "S" and "H".
Image /page/1/Picture/1 description: The image shows the text "K060111" on the top line and "2 of 2" on the second line. The text appears to be handwritten and slightly distorted. The numbers "060111" could be a date or a code, while "2 of 2" suggests that this is the second page of a two-page document.
510(k) Summary - page 2
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- Intended Use
The Intended Use of the DAI-R is for the automatic self-administration of FDA-approved drugs and biologics from standard Glass Barrel 1mL Long Syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R.
- Intended Use
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- Technological Characteristics
The technological characteristics of the DAI-R are the same as other introducer products that are currently marketed in the U.S.
- Technological Characteristics
The DAI-R is made of the same materials as the identified predicate device.
Design and performance features of the DAI-R include a safety mechanism to prevent inadvertent activation. automatic sheathing of the used needle, cutout window on the front assembly, locking tabs to prevent disassembly of the DAI-R once the two subassemblies have been connected, and self-disabling to prevent reuse.
There are no current performance standards for a Syringe Needle Introducer. The DAI-R was assessed using the sections and methods specified in ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods" as they apply to injection devices with non-replaceable prefilled cartridges. Activation force, needle extension, injection time, completeness of injection, functionality, and robustness were assessed; the DAI-R met these requirements and specifications as identified in the ISO standard.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2006
Mr. Lucio Giambattista Managing Director SHL-Medical, USA 23 Vreeland Road, Suite 104 Florham Park, New Jersey 07932
Re: K060141
Trade/Device Name: DAI-RTM Autoinjector Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: April 18, 2006 Received: April 24, 2006
Dear Mr. Giambattista:
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 controls provisions 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Giambattista
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syndite Y. Michau Omd
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
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KOLON 14
510(k) Number (if known):
Device Name: DAI-R™ Autoinjector
Indications for Use:
The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.
Prescription Use __ XX (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthey V. nxt
nesthesiology, General Hospital. Control. Dental Devices
Number: KY60141
§ 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).