(74 days)
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.
Needle-Free Self Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. Needle-Free Injector, Jet Injector
The provided document is a 510(k) Summary for a medical device (cool.click® Needle-Free Jet Injector) and primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and the performance of an AI/ML device in a clinical or technical study.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth for training sets cannot be extracted from this document in the context of an AI/ML device assessment.
The document explicitly states:
- "No new nonclinical or clinical tests were conducted as part of this submission."
- It refers to previously submitted nonclinical and clinical studies for the predicate device (K994384) which demonstrated bioequivalence between needle and cool.click® needle-free delivery of growth hormone (Saizen®).
The core of this submission is a labeling change to expand the indications for use of an existing device to include adults, aligning with updated indications for the drug Saizen®.
However, based on the limited information that is present in the document about the predicate device's studies, I can infer some aspects related to bioequivalence, which was the performance measure used in those predicate studies.
Here's an attempt to answer the questions based on the available information, noting where information is absent or inferred:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a labeling change based on a predicate device, explicit "acceptance criteria" for this specific submission in terms of device performance are not stated in the provided text. The key performance aspect mentioned relates to the predicate device's demonstrated bioequivalence.
| Performance Metric (from Predicate Device Studies) | Acceptance Criteria (Inferred from Bioequivalence Standard) | Reported Device Performance (from Predicate Device Studies) |
|---|---|---|
| Bioequivalence (Needle-free vs. Needle delivery of Saizen®) | Demonstrates comparable pharmacokinetic and pharmacodynamic profiles. | Demonstrated bioequivalence between needle and cool.click® needle-free delivery of growth hormone. |
Note: The specific statistical thresholds (e.g., 90% confidence interval for AUC, Cmax ratios within 80-125%) typically associated with bioequivalence are not provided in this summary but would have been part of the original predicate device's studies.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in this document. This information would have been part of the studies conducted for the predicate device (K994384).
- Data Provenance: Not specified. The studies were "conducted for the predicate cool.click submission K994384." Whether they were prospective or retrospective, and the country of origin, is not mentioned here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this type of device (needle-free jet injector). The "ground truth" in bioequivalence studies is typically the pharmacokinetic and pharmacodynamic data derived from blood samples and clinical observations. It doesn't involve expert interpretation in the way AI/ML diagnostics do.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Bioequivalence studies typically involve statistical analysis of quantitative data, not human adjudication of interpretations.
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
Not applicable. This is a medical device for drug delivery, not an AI/ML diagnostic or assistive technology involving human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device studies, the ground truth was based on pharmacokinetic (PK) and pharmacodynamic (PD) data (e.g., drug concentration in blood, biological response) collected from study participants following administration of Saizen® using both needle and needle-free methods. This would qualify as outcomes data (physiological measurements).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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 TalbertDirector Product DevelopmentDate:March 18, 2005 | Phone: | 800-683-7221, ext. 4144 | Fax: | 503-692-6698 | Email: | MTalbert@bioject.com | Contact: | Melanie TalbertDirector Product Development | Date: | March 18, 2005 | |
| Phone: | 800-683-7221, ext. 4144 | ||||||||||
| Fax: | 503-692-6698 | ||||||||||
| Email: | MTalbert@bioject.com | ||||||||||
| Contact: | Melanie TalbertDirector 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 PoweredFluid Injector | ||||||||||
| Predicate Device(s): | Clicker™ (cool.click®) K994384 | ||||||||||
| Device Description: | Needle-Free Self Injection Device forPersonal Use with Saizen® [somatropin(rDNA origin) for injection].Needle-Free Injector, Jet Injector | ||||||||||
| Intended Use: | Needle-Free Self Injection Device forPersonal Use with Saizen® [somatropin(rDNA origin) for injection]. | ||||||||||
| C. Comparison of Required TechnologicalCharacteristics: | This submission changes the labeling of thecool.click® to expand the indications foruse to include adults in accordance withchanges approved for Saizen® indications.There are no significant changes in thedevice 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.
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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.
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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
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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 ________________________________________________________________________________________________________________________________________________________________
§ 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).