(122 days)
Not Found
No
The description focuses on mechanical and spring-powered mechanisms for automated drug delivery, with no mention of AI or ML.
No.
The device is an automatic drug delivery device for the self-administration of drugs and biologics. It aids in the delivery of a therapeutic substance, but it is not therapeutic in itself.
No
The device is described as a "hand-held mechanical device intended for the automated, subcutaneous, self-administration of FDA-approved drugs and biologics." Its function is drug delivery, not diagnosis.
No
The device description explicitly states that DAI™ is a "hand-held mechanical device" and describes its physical components made of "plastic and metal." It is a hardware device for drug delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- DAI™ Function: The DAI™ device is a mechanical device designed for the delivery of prefilled drugs and biologics subcutaneously. It facilitates the injection process but does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states "automated, subcutaneous, self-administration of FDA-approved drugs and biologics." This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of the device and its role in delivering the contents of a prefilled syringe. It explicitly states that DAI™ "does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe," further indicating it's not involved in analyzing biological samples.
Therefore, the DAI™ device falls under the category of a drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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™.
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.
Product codes
KZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
-
- 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
1
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.
2
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.
3
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
4
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