(177 days)
No
The device description and performance studies focus on the mechanical function and drug delivery characteristics of a needle-free injection device. There is no mention of AI or ML in the document.
No.
The device is a drug delivery system for Saizen®, which is the therapeutic agent. The device itself does not provide therapeutic action.
No
Explanation: The device is a needle-free self-injection device intended for administering a drug (somatropin) for growth hormone deficiency treatment, not for diagnosing a condition.
No
The device description explicitly states it is a "Needle-Free Self-Injection Device" and discusses changes to the "Vitajet 3" hardware. The performance studies focus on the physical interaction of the device with the drug and the patient, not on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone" by administering a drug (Saizen®). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "Needle-Free Self-Injection Device" for administering a drug. This aligns with a drug delivery system, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The studies focus on the device's ability to deliver the drug effectively (pharmacokinetics and pharmacodynamics) and user acceptability (pain, convenience, preference). These are relevant to a drug delivery device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Clicker™ Needle-Free Self-Injection Device is a drug delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is indicated for use with Saizen® [somatropin (rDNAorigin) for . injection] for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Product codes
KZE
Device Description
Clicker™ Needle-Free Self-Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. This submission changes the labeling of the Vitajet 3, (Innova) (K962625) to allow the device to be used for needle-free subcutaneous administration of Saizen® [somatropin (rDNAorigin) for injection]. There are no other significant changes to the Vitajet 3 (Innova) in device design or function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
children
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)
LABORATORY STUDIES
- SHEAR STRESS TESTING: Protocol P-00026-01 was conducted to determine the effect of shear stress on Saizen®. Two lots of 5.0 mg vial Saizen® and one lot of 8.8 mg vial Saizen® were tested. Results were within assay variability for high-pressure liquid chromatography (HPLC) analysis, physical tests and pH, indicating shear stress caused by Clicker™ did not physically alter Saizen® structure.
- CHEMICAL COMPATIBILITY TESTING (CLEAR VIEW NOZZLE STUDY): Protocol P-00028-01 was performed to assess interaction of growth hormone with the plastic components (Sterile plastic Stem Tip and Clear View Nozzle) of the needle-free jet-injector. Two lots of 5.0 mg vial Saizen® and one lot of 8.8 mg vial Saison® were tested. Results were within assay variability for HPLC analysis, physical tests and pH, indicating suitability for use with Saizen®.
- VIAL CONNECTOR STUDY: Protocol P-00025-01 examined the Vial Connector. Growth hormone samples were observed at seven and fourteen days for particulates. Samples were also tested for pH and purity by SE-HPLC. Results demonstrated within-assay variability for HPLC analysis, physical tests and pH, indicating suitability for use with Saizen®.
- BIOBURDEN STUDY: Protocol P-00027-02 investigates the effect of repeated use of Clicker™ on microorganism growth. Components (plastic Stem Tip and Clear View Nozzle) can be used for up to seven days, and reconstituted Saizen® for up to 14 days. Multiple drug lots were tested with 12 jet-injectors. Liquid contents injected from the nozzle showed no microorganism growth. The nozzle surface showed growth in one sample, and the Stem Tip in two samples (non-pathogenic Staphylococcus species and Aspergillus glaucus, Bacillus lichenformis). The vial contents exhibited growth on one sample (non-pathogenic mold Aspergillus versicolor). The vial adapter surface showed skin contaminants (non-pathogenic Staphylococcus species). All recovered isolates were determined not to be Escherichia coli, Pseudomonas aeauginosa, Salmonella or Staphylococcus aureus. Conclusion: no clinically significant microorganisms found within the nozzle or Saizen® vial over 14 days; only minor expected surface contaminants on outer surfaces.
CLINICAL STUDIES
- PHARMACOKINETIC AND PHARNACODYNAMIC CYNAMIC STUDIES IN ADULTS: Randomized, single-dose, two-way crossover relative bioavailability study of Saizen® administered subcutaneously by needle or needle-free device in 21 normal healthy adult subjects (ages 18-40 years). Measured GH levels from both methods were similar over 24 hours. Maximum GH concentration and peak time were not statistically different. For AUC, the 90% confidence interval for the ratio was (0.95, 1.12), within (80%, 125%) for bioequivalence. For Cmax, the 90% confidence interval for the ratio was (0.81, 1.20), within (80%, 125%). Untransformed tmax showed no statistically significant differences. Serum IGF1 values measured every six hours were very similar. Analog scales evaluated drug penetration, bleeding, and bruising; no statistically significant difference between treatments. No serious adverse events or withdrawals. The adult questionnaire indicated a trend toward less pain with jet-injector (p = 0.093). Highly significant preference for needle-free jet-injector for "ease of use" (p = 0.017), "convenience" (p = 0.004), "pleasantness" (p = 0.011), "less apprehension" (p = 0.0110), and "overall preference" (p = 0.053).
- QUESTIONNAIRES IN CHILDREN WITH TYPE I DIABETES MELLITUS: 29 adolescents (ages 12-18 years) with one to five years of insulin dependent diabetes mellitus compared a single, self-administered needle-free dose of saline with previous needle injections of insulin. Questionnaires showed highly significant differences for "pain" and "unpleasantness" favoring the needle-free jet-injector. 22 to 7 ratio chose needle as more painful (p
§ 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).
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Image /page/0/Picture/1 description: The image shows the text "K994384 1 of 6" in a handwritten style. The text appears to be a label or identifier, possibly indicating a document or item number. The phrase "1 of 6" suggests that this is the first page or item in a series of six.
510(k) Summary (As required by 21 CFR 807.92(a))
ﻪ
A. Submitter Information
Bioject, Inc. 7620 SW Bridgeport Road Portland, Oregon 97224
Phone: 800-683-7221 ext. 424 Fax: 503-624-9002 Email: nancy@bioject.com Contact: Nancy J. Gertlar Manager, QA/RA December 17, 1999 Date:
B Device Information Trade/Proprietary Name:
Common Name:
Classification Name:
Predicate Device(s):
Device Description:
Intended Use:
- C Comparison of Required Technological Characteristics:
Jet Injector, Non-Electrically Powered Fluid Injector
Needle Free Injector, Jet Injector
Clicker™
Clicker™ Needle-Free Self-Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. Needle Free Injector, Jet Injector
Clicker™ Needle-Free Self-Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection].
This submission changes the labeling of the Vitajet 3, (Innova) (K962625) to allow the device to be used for needle-free subcutaneous administration of Saizen® [somatropin (rDNAorigin) for injection].
There are no other significant changes to the Vitajet 3 (Innova) in device design or function.
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D Summary and Conclusion of Nonclinical and Clinical Tests:
GROWTH HORMONE DELIVERY USING A NEEDLE-FREE JET-INJECTOR
A number of clinical and laboratory studies were completed to prepare for an FDA submission for Saizen to be used with a needle-free device. These included laboratory studies designed to address the ability of Saizen to remain intact after administration through the jet-injector and measurement of any Saizen , which may adsorb to the plastic component parts. In addition, procedures were developed to measure and identify any microorganisms that may develop after seven daily injections with the same disposable plastic nozzle and vial connector.
LABORATORY STUDIES
The goals of the laboratory studies were to evaluate potential shearing and fragmentation of Saizen® and the interaction of growth hormone with the various plastic device components. In addition, a Bioburden study was performed to evaluate microorganism growth in and on the disposable clear nozzle as well as in the vial itself and on the vial connector. Four protocols were completed to reach the above goals.
SHEAR STRESS TESTING
Clicker" utilizes a spring to induce a high-pressure injection of growth hormone through the skin. Protocol P-00026-01 was conducted to determine the effect of shear stress on Saizen®. A total of two lots of the 5.0 mg vial Saizen® and one lot of 8.8 mg vial Saizen® were tested. Technical report R-00055-02 summarizes the results. Results were within assay variability for high-pressure liquid chromatography (HPLC) analysis, physical tests and pH. Therefore, shear stress caused by Clicker™ did not physically alter the structure of Saizen®.
CHEMICAL COMPATIBILITY TESTING
CLEAR VIEW NOZZLE STUDY
Clicker" utilizes a sterile plastic Stem Tip and Clear View Nozzle to perform a highpressure injection of growth hormone through the skin. Protocol P-00028-01 was performed to assess interaction of growth hormone with the plastic components of the needle-free jet-injector. Two lots of the 5.0 mg vial Saizen® and one lot of 8.8 mg vial Saison® were tested. Technical report R-00056-02 summarizes the results. Results were within assay variability for HPLC analysis, physical tests and pH. Therefore, the Clear View Nozzle and Stem Tip are suitable for use with Saizen®
VIAL CONNECTOR STUDY
Protocol P-00025-01 examined the Vial Connector needed on the vial of growth hormone to facilitate drawing up the material into the injector. The growth hormone
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samples were observed at seven and fourteen days for particulates by holding up to the light, checking against black paper and checking against white paper. The samples were also tested for pH and assessed for purity by SE-HPLC. Technical report R-00058-02 summarizes these results. Results demonstrated within- assay variability for HPLC analysis, physical tests and pH. Therefore, the Vial Connector is suitable for use with Saizen®.
BIOBURDEN STUDY
Protocol P-00027-02 investigates the effect of repeated use of Clicker" on the number and pathogenicity of microorganisms noted on the various component parts. The components (plastic Stem Tip and Clear View Nozzle) can be used for up to seven days, while the reconstituted vial of Saizen® can be used for up to 14 days. This study was conducted to determine the amount and type of microorganism growth on the injector components, in the vial and in the injected drug after 14 days of use.
Multiple drug lots were tested with 12 jet-injectors. Technical report R-00057-01 summarizes the results. The liquid contents injected from the nozzle showed no microorganism growth in any sample, while the nozzle surface itself showed growth in only one sample. The Stem Tip exhibited growth in two samples, but did not show growth on the same, more concentrated filtration samples. One culture grew a nonpathogenic Staphylococcus species and another grew a mold (Aspergillus glaucus) and non-pathogenic bacteria (Bacillus lichenformis). The vial contents exhibited growth on only one sample. This single isolate was a non-pathogenic mold (Aspergillus versicolor). The vial adapter surface showed multiple occurrences of skin contaminants (non- pathogenic Staphylococcus species) only. All recovered isolates were determined not to be Escherichia coli, Pseudomonas aeauginosa, Salmonella or Staphylococcus aureus by screening on selective agar.
In summary, there are no clinically significant microorganisms found within the nozzle or within the Saizen® vial over a period of 14 days. Only minor expected surface contaminants were seen on the outer surface of the Vial Connector, Stem Tip and Clear View nozzle.
CLINICAL STUDIES
Clinical studies included a randomized crossover pharmacokinetic, pharmacodynamic study comparing a conventional needle injection to Clicker™. A second study evaluated the acceptability of the needle-free device following a single jet-injection compared to needle injection in 29 children (ages 12-18), with Type I diabetes mellitus. The children with diabetes mellitus were taking daily or more frequent insulin needle injections for a period of one to five years. Two separate clinical studies were completed on 21 adults and 29 children.
PHARMACOKINETIC AND PHARNACODYNAMIC CYNAMIC STUDIES IN ADULTS
A randomized, single-dose, two-way crossover relative bioavailability study of Saizen® administered subcutaneously by needle or needle-free device in normal
3
healthy adult subjects (ages 18- 40 years) was completed to determine bioequivalence between the conventional subcutaneous needle injection of GH and GH administered using a needle-free device. Statistical bioequivalence analyses were based on 21 subjects. In the clinical pharmacokinetic study, the measured GH levels from subjects using the needle injection and the needle-free device were similar during the entire 24 hours of blood monitoring. (Figure 1)
Image /page/3/Figure/2 description: The image is a graph titled "Figure 1" that shows the serum concentration of growth hormone over a 24-hour period. The x-axis represents the sampling time in hours, ranging from 0 to 24. The y-axis represents the serum concentration (geometric mean) of growth hormone. Two lines are plotted on the graph, representing two different treatments: a jet injector and a syringe.
The maximum concentration of GH and the peak time for the maximum GH concentration were also not statistically different. The data for AUC, AUCtiast) and Cmax were log transformed prior to analysis. The data for tmax and t1/2 were assessed for adherence to assumptions. For AUC 138, the 90 % confidence interval for the ratio of test to reference expressed, as a percentage was (0.95, 1.12) falling within the (80%, 125%) interval required for bioequivalence as specified in the protocol. For Cmax the 90 % confidence interval for the ratio of test to reference expressed as a percentage was (0.81, 1.20), falling within the (80%, 125%) interval required for bioequivalence as specified in the protocol.
For untransformed tmax the p-values associated with the Shapiro-Wilks tests of normality were not statistically significant for intrasubject error (p = 0.428) and
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intersubject error (p = 0.857). The test for formulation differences between the reference formulation and the test formulation twas not statistically significant (p = 0.523). Period effects were also not statistically significant (p = 0.472).
The serum IGF1 values measured every six hours for 24 hours after injection were very similar when comparing both the needle and needle-free device. (Figure 2) After log transforming the data, the p-values for the Shapiro-Wilks test of normality for both the intrasubject and intersubject error were not significant (p = 0.840 for intrasubject error, p = . 0599 for intersubject error).
Image /page/4/Figure/2 description: The image is a line graph titled "Figure 2" that shows the mean serum concentration of IGF-1 over a 26-hour period. The x-axis represents the sampling time in hours, ranging from 0 to 26. The y-axis represents the mean serum concentration of IGF-1, ranging from 100 to 400. Two lines are plotted on the graph, representing two different treatments: Jet Injector and Syringe.
Analog scales were developed to evaluate drug penetration of the skin, bleeding and bruising immediately after injection, thirty minutes after injection and twenty-four hours after injection. Inspections of these count data suggested that there was no statistically significant difference between both treatments (needle vs. needle- free) with respect to the number of subjects injected and events at various time points (0, 30 minutes and 24 hours after injection).
There were no serious adverse events or deaths in this study and no subjects withdrew prematurely from the study. The mild adverse reactions that were reported did not appear to be device related.
The adult questionnaire (ages 18-40 years) indicated a trend toward less pain with the jet-injector (p = 0.093). However, the response to specific questions relating to "ease of use" (p = 0.017), " convenience" (p = 0.004), "pleasantness" (p = 0.011), " less
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apprehension" (p = 0.0110 and "overall preference" (p = 0.053) showed a highly significant preference for the needle-free jet-injector over the conventional needle injection.
QUESTIONNAIRES IN CHILDREN WITH TYPE I DIABETES MELLITUS
Twenty-nine adolescents with one to five years of insulin dependent diabetes mellitus were asked to compare a single, self-administered needle-free dose of saline with the previous six months of needle injections of insulin. Questionnaires were administered shortly after their needle-free injection. The questionnaires in the group of 29 adolescents with Type I diabetes mellitus (ages 12-18 years) demonstrated highly significant differences relating to both "pain" and "unpleasantness" favoring the needle-free jet-injector over needle injections. The subjects chose the needle as the method that would hurt more by a count of 22 to 7. This confirmed the level of pain data and was again highly significant, p