(74 days)
No
The summary describes a needle-free injection device and its intended use, but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
This device is for the Needle-Free Self Injection of Saizen® (somatotropin) to replace endogenous growth hormone in adults with growth hormone deficiency, which is a therapeutic purpose.
No
Explanation: This device is described as a needle-free self-injection device for personal use, indicated for administering medication (somatotropin). It's a drug delivery system, not a device that diagnoses a condition or disease.
No
The device description explicitly states "Needle-Free Self Injection Device" and "Needle-Free Injector, Jet Injector," indicating a physical hardware component for injection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Needle-Free Self Injection of Saizen®... for the replacement of endogenous growth hormone in adults with growth hormone deficiency." This describes a device used to administer a therapeutic substance directly into the body, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description "Needle-Free Self Injection Device for Personal Use with Saizen®... Needle-Free Injector, Jet Injector" further reinforces that it's a drug delivery device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
In summary, this device is a drug delivery system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Needle-Free Self Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection].
This product is indicated for Needle-Free Self Injection of Saizen® [somatotropin (rDNA origin) for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
Product codes
KZE
Device Description
Needle-Free Self Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. Needle-Free Injector, Jet Injector
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
Adults
Intended User / Care Setting
Personal Use
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)
No new nonclinical or clinical tests were conducted as part of this submission. Non clinical and clinical studies with Saizen® were conducted for the predicate cool.click submission K994384. The predicate submission included Saizen® pharmacokinetic and pharmacodynamic studies using the cool.click injector in adults demonstrating bioequivalence between needle and needle-free delivery of growth hormone.
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
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).
0
K050734
Page 1 of 2
JUN 3 - 2005
510(k) Summary
(As required by 21 CFR 807.92(a))
| A. Submitter Information | Bioject Medical Technologies, Inc.
20245 S.W. 95th Ave.
Tualatin, OR 97062 | | | | | | | | | | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|------|--------------|--------|----------------------|----------|-------------------------------------------------|-------|----------------|
| | Phone:800-683-7221, ext. 4144Fax:503-692-6698Email:MTalbert@bioject.comContact:Melanie Talbert
Director Product DevelopmentDate:March 18, 2005 | Phone: | 800-683-7221, ext. 4144 | Fax: | 503-692-6698 | Email: | MTalbert@bioject.com | Contact: | Melanie Talbert
Director Product Development | Date: | March 18, 2005 |
| Phone: | 800-683-7221, ext. 4144 | | | | | | | | | | |
| Fax: | 503-692-6698 | | | | | | | | | | |
| Email: | MTalbert@bioject.com | | | | | | | | | | |
| Contact: | Melanie Talbert
Director Product Development | | | | | | | | | | |
| Date: | March 18, 2005 | | | | | | | | | | |
| B. Device Information | | | | | | | | | | | |
| Trade/Proprietary Name: | cool.click® | | | | | | | | | | |
| Common Name: | Needle-Free Jet Injector | | | | | | | | | | |
| Classification Name: | Jet Injector, Non-Electrically Powered
Fluid Injector | | | | | | | | | | |
| Predicate Device(s): | Clicker™ (cool.click®) K994384 | | | | | | | | | | |
| Device Description: | Needle-Free Self Injection Device for
Personal Use with Saizen® [somatropin
(rDNA origin) for injection].
Needle-Free Injector, Jet Injector | | | | | | | | | | |
| Intended Use: | Needle-Free Self Injection Device for
Personal Use with Saizen® [somatropin
(rDNA origin) for injection]. | | | | | | | | | | |
| C. Comparison of Required Technological
Characteristics: | This submission changes the labeling of the
cool.click® to expand the indications for
use to include adults in accordance with
changes approved for Saizen® indications.
There are no significant changes in the
device design or function. | | | | | | | | | | |
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K050734
Page 2 of 2
D. Summary and Conclusion of Nonclinical and Clinical Tests: No new nonclinical or clinical tests were conducted as part of this submission. Non clinical and clinical studies with Saizen® were conducted for the predicate cool.click submission K994384. The predicate submission included Saizen® pharmacokinetic and pharmacodynamic studies using the cool.click injector in adults demonstrating bioequivalence between needle and needle-free delivery of growth hormone.
Summary:
This submission describes the labeling changes associated with the changes to indications for use for the cool.click® Needle-Free Self Injection Device for Personal Use with Saizen®. Previously submitted nonclinical and clinical studies have demonstrated the bioequivalence between needle and cool.click® needle-free delivery of growth hormone.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The seal is surrounded by the words "Department of Health and Human Services USA" in a circular arrangement.
JUN 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Susan Frank, J.D. Director, Regulatory Affairs Bioject Medical Technologies, Incorporated 20245 S.W. 95th Avenue Tualatin, Oregon 97062
Re: K050734
Trade/Device Name: cool.click® Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: March 18, 2005 Received: March 21, 2005
Dear Ms. Frank:
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. Frank
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,
Quite y. Michael ms.
Ski-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
4
Indications for Use
510(k) Number:K050734
Device Name: cool.click®
Indications For Use: This product is indicated for Needle-Free Self Injection of Saizen® [somatotropin (rDNA origin) for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chita Dure
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________