(24 days)
Not Found
No
The summary describes a mechanical auto-injector and does not mention any AI/ML components or functionalities.
No
The device aids in the self-administration of drugs but does not itself provide therapy.
No
Explanation: The device description clearly states its purpose is "assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products". It is a delivery device for medication, not for diagnosing a medical condition.
No
The device description explicitly states it is a "single-use, automatic, disposable and hidden-needle auto-injector," which are physical hardware components.
No, 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.
- ASI-2 Function: The ASI-2 is a device designed to administer a drug product into the body (subcutaneously). It does not perform any tests on samples taken from the body.
The description clearly states its purpose is to assist with the self-administered subcutaneous injection of drug products. This is a drug delivery device, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Auto Safety Injector 2 (ASI-2) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products with non-viscous (aqueous) liquid formulations, which are presented in standard 1 ml long BD Hypak® pre-filled syringes with staked needles. The ASI-2 is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
Product codes
KZH
Device Description
The ASI-2 is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.
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 use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive design verification, functional and performance testing have been conducted. The information provided in this premarket notification demonstrates that the ASI-2 device is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
OCT 02 2008
Image /page/0/Picture/1 description: The image contains a sequence of characters that appear to be handwritten. The characters read 'Koasa87'. The writing style is somewhat cursive, with some letters connected. The numbers '8' and '7' are clearly distinguishable at the end of the sequence.
| Image: The Medical House logo | MEDICAL HOUSE PRODUCTS LTD | |
|---|---|---|
| Pre-Market Notification | Section 5.0 | Revision No: 01 |
| Product: Auto Safety | ||
| Injector-2 (ASI-2) | 510(k) Summary | Effective Date: |
| 5th September 2008 |
510(k) Summary [As required by 21 CFR 907.92(a)]
A. Submitter Information:
| Submitter: | Medical House Products Limited
199 Newhall Road
Sheffield, S9 2QJ
United Kingdom |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Rose Y Guang
Quality, Regulatory Affairs & Operations Director
E-mail: rguang@themedicalhouse.com
Phone: (+) 44 1142 619 011
Fax (+) 44 1142 431 597 |
Date: 5th September 2008
B. Device Information:
Trade/ Proprietary Name: Auto Safety Injector-2 (ASI-2)
| Common Name: | Auto-Injector |
|---|---|
| Classification Name: | Introducer, syringe needle |
| Predicate Device: | Compact Auto-Safety Injector (510(k) No: K073476) |
| Device Description: | The ASI-2 is a single-use, automatic, disposable and |
| hidden-needle auto-injector for the self-administration of | |
| liquid drug products. | |
| Intended Use: | The Auto Safety Injector 2 (ASI-2) is indicated for assisting |
| the self-administered subcutaneous injection of fixed doses | |
| of FDA-approved drug products with non-viscous (aqueous) | |
| liquid formulations, which are presented in standard 1 ml | |
| long BD Hypak® pre-filled syringes with staked needles. | |
| The ASI-2 is primarily intended for home use by patients to | |
| aid and support their treatment regime or may be used by | |
| Health Care Professionals or caregivers. |
1
Image /page/1/Picture/0 description: The image shows the text "The Medical House" in a stylized font. An arrow originates from the text and points towards a building in the background. The building appears to be a medical facility.
MEDICAL HOUSE PRODUCTS LTD
| Pre-Market Notification | Revision No: 01 | |
|---|---|---|
| Section 5.0 | ||
| Product: Auto Safety | ||
| Injector-2 (ASI-2) | 510(k) Summary | Effective Date: |
| 561 September 2008 | ||
| a de la provincia de l'artifica de l'Article de l'Article de l'Article de l'Article de l'Article de l'Article de l'Article de l'Article de l'Article de l'Article de l'Article |
C. Comparison of Required Technological Characteristics
The ASI-2 device applies the same technological characteristics as the predicate device. It is designed similarly to the devices that are currently marketed in the U.S.
The key difference between the ASI-2 device and the predicate device is that the ASI-2 device is not specifically intended for viscous liquid formulations.
D. Summary and Conclusion of Performance Tests
Extensive design verification, functional and performance testing have been conducted. The information provided in this premarket notification demonstrates that the ASI-2 device is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 02 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rose Y. Guang Quality, Regulatory Affairs & Operations Director Medical House Products Limited 199 Newhall Road Sheffield, S9 2QJ UNITED KINGDOM
Re: K082587
Trade/Device Name: Auto Safety Injector 2 (ASI-2) Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: September 5, 2008 Received: September 8, 2008
Dear Ms. Guang:
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 - Ms. Guang
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 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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Image /page/4/Picture/0 description: The image shows the text "The Medical House" in a stylized font. A curved line underlines the text, leading to a thick black arrow pointing towards the right. The arrow's head is filled with a textured pattern, adding visual interest to the design.
MEDICAL HOUSE (ASI) LTD
| Pre-Market Notification | Revision No: 01 |
|---|---|
| Product: Auto-Safety | |
| Injector 2 (ASI-2) | Effective Date: |
| 5th September 2008 |
Section 4.0
Indication For Use Statement
510(k) Number: Device Name: Auto Safety Injector 2 (ASI-2)
Indications For Use;
The Auto Safety Injector 2 (ASI-2) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products with non-viscous (aqueous) liquid formulations, which are presented in standard Iml long BD Hypak® prefilled syringes (PFS) with staked needles.
The ASI-2 is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sa Qeh Pes Chulin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082587