(122 days)
DAI™ is a hand-held mechanical device intended for the automated, subcutaneous, selfadministration of FDA-approved drugs and biologics. DAI™ is designed to be used with the standard 1.0mL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAI™ is for use in the home environment to aid and support prescribed treatment and therapy.
DAI™ is an automatic drug delivery device that is used for the subcutaneous administration of drugs and biologics from standard 1.0mL long glass syringes with staked needle from 25g to 27g and 12.7mm in length that are prefilled prior to use in DAI™ is a single-use, disposable, syringe needle introducer device that is spring-powered and designed to administer the entire contents of the prefilled syringe during one injection. A DAI™ injection consists of the automatic insertion of the syringe needle to a predetermined depth into the skin, followed by the automatic delivery of the syringe contents.
DAT™ consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self injection. The assembled DAI has a tubular design with a needle end and a power assembly with activation button end. DAI™ components and subassemblies are made of plastic and metal. DAI™ does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
The provided 510(k) summary for the SHL DAI™ auto-injector does not contain a detailed study meeting all the requested criteria for an AI/ML device. This is a clearance for a medical device (auto-injector), not an AI/ML diagnostic or predictive tool, and thus the structure of the provided information is different.
However, I can extract the relevant information from the document that pertains to performance assessment and acceptance criteria for this type of device, as much as possible, and note where information specific to AI/ML studies is not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 11608:2000 as applicable) | Reported Device Performance |
|---|---|
| Activation Force | Met all requirements and specifications |
| Needle Extension | Met all requirements and specifications |
| Injection Time | Met all requirements and specifications |
| Completeness of Injection | Met all requirements and specifications |
| Functionality | Met all requirements and specifications |
| Robustness | Met all requirements and specifications |
| Safety mechanism to prevent inadvertent activation | Design feature of DAI™ |
| Automatic recovering of the used needle | Design feature of DAI™ |
| Cutout window for syringe inspection | Design feature of DAI™ |
| Locking tabs to prevent disassembly | Design feature of DAI™ |
| Self-disabling after use | Design feature of DAI™ |
2. Sample size used for the test set and data provenance
- Sample Size: Not explicitly stated. The document mentions "DAI™ 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." This standard would define the sample sizes for various tests.
- Data Provenance: Not explicitly stated. It's implied to be data generated from testing the physical device according to ISO 11608:2000. It's a prospective testing process following the standard. Country of origin not specified, but the applicant is SHL Medical, USA.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not Applicable in the context of an auto-injector. Ground truth for this type of device is established through objective physical measurements and functional tests, not expert interpretation of diagnostic images or data.
4. Adjudication method for the test set
- Not Applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective assessments (e.g., image interpretation). The performance of an auto-injector is measured objectively against predefined specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size
- No, not applicable. MRMC studies are used to assess the impact of a diagnostic aid (like AI) on human reader performance. This device is an auto-injector, not a diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit. The "device performance" described is inherently "standalone" in that it refers to the physical device's automated function (needle insertion, drug delivery, safety features) without human interpretative input once activated. However, this is not an "algorithm only" study as it pertains to a mechanical device.
7. The type of ground truth used
- Objective physical measurements and functional test outcomes. For example, needle extension would be measured directly, injection time would be timed, and completeness of injection verified. The ground truth is the physical reality of the device's operation against its design specifications and the requirements of ISO 11608:2000.
8. The sample size for the training set
- Not Applicable in the context of an AI/ML device. This device is not AI/ML based and does not have a "training set" in that sense. Its design is based on engineering principles and validated through physical testing.
9. How the ground truth for the training set was established
- Not Applicable for this type of device. There is no AI/ML training set.
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KOS-0934
Image /page/0/Picture/1 description: The image shows the logo for SHL Medical. The logo consists of a stylized graphic to the left of the text "SHL MEDICAL". Below the text is a smaller line of text that reads "A Scandinavian Health Group Company".
JUN 2 4 2005
510(k) SUMMARY
- 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: February 17, 2005
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- Device Information
Device Trade Name: DAI™ Device Common Name: Auto-injector Classification Name: Introducer, Syringe Needle
- Device Information
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- Device to which substantial equivalence is claimed Device Name: Owen Mumford Autoject Mini 510(k) Clearance Number: K000482 Device Common Name: Syringe needle introducer Classification Name: Introducer, Syringe Needle
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- Device Description
DAI™ is an automatic drug delivery device that is used for the subcutaneous administration of drugs and biologics from standard 1.0mL long glass syringes with staked needle from 25g to 27g and 12.7mm in length that are prefilled prior to use in DAI™ is a single-use, disposable, syringe needle introducer device that is spring-powered and designed to administer the entire contents of the prefilled syringe during one injection. A DAI™ injection consists of the automatic insertion of the syringe needle to a predetermined depth into the skin, followed by the automatic delivery of the syringe contents.
DAT™ consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self injection. The assembled DAI™ has a tubular design with a needle end and a power assembly with activation button end. DAI™ components and subassemblies are made of plastic and metal. DAI™ does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
Page 1 of 2
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JUN 2 4 2005
Image /page/1/Picture/2 description: The image shows the logo for SHL Medical. The logo consists of a stylized graphic to the left of the text "SHL MEDICAL". Below the text is a tagline that is difficult to read due to the image quality.
510(k) Summary - page 2
- Intended Use
The Intended Use of DAI™ is for the automatic self-administration of FDA-approved drugs and biologics from standard 1.0mL Long Syringes with Needle that have been prefilled prior to use with DAI™.
- Technological Characteristics
The technological characteristics of DAI™ are the same as other introducer products that are currently marketed in the U.S.
DAT™ is made of materials that have been evaluated for use in manufacturing medical devices, including syringe needle introducers. DAI™ uses a pre-compressed stainless steel spring that when released by the activation of the device, drives a plunger rod onto the stopper of the svringe to expel the contents and effect the injection.
Design and performance features of DAI™ include a safety mechanism to prevent inadvertent activation, automatic recovering of the used needle, cutout window on the front assembly to permit inspection of the syringe, locking tabs to prevent disassembly of DAI™ once the two subassemblies have been connected, and self-disabling after use.
No performance standards have been established for Introducer, Syringe Needle. DAI™ 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; DAI™ met all requirements and specifications.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
JUN 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lucio Giambattista Managing Director SHL Medical, USA 23 Vreeland Road, Suite 104 Florham Park, New Jersey 07932
Re: K050434
Trade/Device Name: SHL DAI™ Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: June 20, 2005 Received: June 22, 2005
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 (QS) 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,
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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Indications for Use
510(k) Number (if known):
Device Name: SHL DAI™
Indications for Use:
DAI™ is a hand-held mechanical device intended for the automated, subcutaneous, selfadministration of FDA-approved drugs and biologics. DAI™ is designed to be used with the standard 1.0mL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAI™ 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)
Chis un
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: __ cus 5 44
§ 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).