(88 days)
The Compact Auto Safety Injector (CASI) is indicated for assisting the selfadministered subcutaneous injection of fixed doses of FDA approved drug products with viscous liquid formulations, which are presented in standard 1ml long BD Hypak® pre-filled syringes with staked needles. The CASI 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.
The CASI is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.
The provided document is a 510(k) summary for the Compact Auto-Safety Injector (CASI) and a subsequent FDA clearance letter. It outlines the device's description, intended use, and comparison to a predicate device, as well as a general statement about performance testing.
However, the document does not contain specific details regarding acceptance criteria, reported device performance tables, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, or specific results of MRMC or standalone studies.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device, a common pathway for medical device clearance in the US.
Here's a breakdown of the information that can be extracted and what is missing:
1. Acceptance Criteria and Reported Device Performance
Missing. The document states that "Extensive design verification, functional and performance testing have been conducted" and that "The information provided in this premarket notification demonstrates that the CASI device is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device." However, it does not provide a table specifying acceptance criteria or the numerical performance metrics achieved by the CASI device against those criteria.
2. Sample size used for the test set and the data provenance
Missing. The document mentions "extensive design verification, functional and performance testing" but does not provide details on the sample size of the test sets used for these evaluations. It also does not specify data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing. This information is not present in the provided 510(k) summary. The testing described appears to be primarily engineering-focused (design verification, functional, and performance testing) rather than clinical studies requiring expert ground truth establishment in a diagnostic context.
4. Adjudication method for the test set
Missing. As the document doesn't detail the types of tests that would require adjudication (e.g., image interpretation), this information is not provided.
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
Missing. The CASI is an auto-injector device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing. Again, this is an auto-injector, not an algorithm. The "performance tests" would refer to mechanical and functional aspects of the device itself, not an algorithm's standalone performance.
7. The type of ground truth used
Missing. Given the nature of the device (an auto-injector), "ground truth" would likely relate to objective measurements of its mechanical function (e.g., dose delivery accuracy, needle retraction success, injection force, usability). The document does not specify what objective standards or methods were used to determine the "truth" for these functional tests.
8. The sample size for the training set
Missing. As this device is not a machine learning or AI-based product, there would be no "training set" in the computational sense. The "design verification" and "performance testing" are typically conducted on prototypes or production units of the device.
9. How the ground truth for the training set was established
Missing. As there is no "training set" in the AI sense, this information is not applicable and therefore not provided.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence of a medical device (an auto-injector) to a predicate device. It confirms that performance tests were conducted to ensure safety and effectiveness but does not delve into the detailed methodological aspects of those tests that would be relevant for an AI/ML-based device evaluation (e.g., specific acceptance criteria tables, sample sizes, expert involvement, or AI-specific study types).
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K073476
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| The Medical House | |
|---|---|
| And And Ass " various would of the |
MAR - 7 2008
MEDICAL HOUSE (ASI) LTD
| Pre-Market Notification | Revision No: 02 | |
|---|---|---|
| ------------------------- | -- | ----------------- |
Section 5.0
| Product: Compact Auto-Safety Injector (CASI) | 510(k) Summary | Effective Date: 05 March 2008 |
|---|---|---|
| ---------------------------------------------- | ----------------------- | ------------------------------- |
510(k) Summary [As required by 21 CFR 907.92(a)]
A. Submitter Information:
| Submitter: | Medical House (ASI) Limited199 Newhall RoadSheffield, S9 2QJUnited Kingdom |
|---|---|
| Contact person: | Rose Y GuangQuality, Regulatory Affairs & Operations DirectorE-mail: rguang@themedicalhouse.comPhone: (+) 44 1142 619 011Fax (+) 44 1142 431 597 |
Date: March 05 2008
B. Device Information:
Trade/ Proprietary Name: Compact Auto-Safety Injector (CASI)
| Common Name: | Auto-Injector |
|---|---|
| Classification Name: | Introducer, syringe needle |
| Predicate Device: | Modification to Autoject Mini K000482 |
| Device Description: | The CASI is a single-use, automatic, disposableand hidden-needle auto-injector for the self-administration of liquid drug products. |
| Intended Use: | The Compact Auto-Safety Injector (CASI) isindicated for assisting the self-administeredsubcutaneous injection of fixed doses of FDAapproved drug products with viscous liquidformulations, which are presented in standard 1mllong BD Hypak® pre-filled syringes with stakedneedles. The CASI is primarily intended for homeuse by patients to aid and support their treatmentregime or may be used by Health Care Professionalsor caregivers. |
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K07 3476
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| MEDICAL HOUSE (ASI) LTD | ||
|---|---|---|
| Pre-Market Notification | Section 5.0510(k) Summary | Revision No: 02 |
| Product: Compact Auto-Safety Injector (CASI) | Effective Date:05 March 2008 |
C. Comparison of Required Technological Characteristics
The CASI 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 of the CASI is that the syringe needle is retracted into the device following injection, rather than remaining exposed or simply covered as in the predicate device. Due to the technological identity and equivalent indications for use of the CASI device and the predicate device, no additional safety items were identified.
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 CASI device is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the left.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rose Y. Guang Quality, Regulatory Affairs & Operations Director Medical House (ASI) Limited 199/201 Newhall Road Sheffield S9 2QJ UNITED KINGDOM
MAR - 7 2008
Re: K073476
Trade/Device Name: Compact Auto Safety Injector (CASI) Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: November 30, 2007 Received: December 10, 2007
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.
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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 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.
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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MEDICAL HOUSE (ASI) LTD
| Pre-Market Notification | Section 4.0 | Revision No: 02 |
|---|---|---|
| Product: Compact Auto-Safety Injector (CASI) | Indication For Use Statement | Effective Date: 05 March 2008 |
510(k) Number: K073476
Device Name: Compact Auto Safety Injector (CASI)
Indications For Use:
The Compact Auto Safety Injector (CASI) is indicated for assisting the selfadministered subcutaneous injection of fixed doses of FDA approved drug products with viscous liquid formulations, which are presented in standard 1ml long BD Hypak® pre-filled syringes with staked needles.
The CASI 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cusack Verna
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 473476
§ 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).