(55 days)
The PharmaJet® Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet® Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.
The PharmaJet® Stratis 0.5 mL Needle-free Injection System is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet® System consists of an injector, a reset station, a single use, sterile disposable filling adapter, and a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet® System are unique and cannot be used with any other needle-free system.
The provided document describes a Special 510(k) Premarket Notification for the PharmaJet® Stratis 0.5 mL Needle-free Injection System. This submission focuses on demonstrating substantial equivalence to a predicate device (PharmaJet® 0.5 mL Needle-free Injection System, K081532) rather than establishing novel safety and effectiveness criteria through extensive clinical trials. Therefore, the information typically available for AI/ML device studies (such as MRMC studies, detailed expertise of adjudicators, specific ground truth methods beyond bench and animal testing, and large training/test sets for algorithm performance) is not directly applicable or available in this type of submission.
The "acceptance criteria" here largely refer to meeting the requirements of the Product and Engineering Specifications, essential requirements of ISO21649:2006, and demonstrating substantial equivalence to the predicate device through various non-clinical and animal studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document emphasizes substantial equivalence to a predicate device. Acceptance criteria are primarily regulatory and standard-based, rather than performance metrics of an AI model. "Reported Device Performance" for this submission focuses on demonstrating these equivalences and compliance.
| Acceptance Criteria Category | Specific Acceptance Criteria (from ISO 21649:2006 & other tests) | Reported Device Performance (Summary) |
|---|---|---|
| Robustness | Product and Engineering Specifications | System meets requirements |
| ISO 21649:2006 Compliance | Requirements and test methods for Needle-free injectors for medical use | Yes (compliant) |
| Environmental Stress | Temperature, storage temperature, free-fall, vibration, shock (per ISO 21649:2006) | Successfully completed |
| Dose Accuracy | Per ISO 21649:2006 | Successfully completed |
| Life Cycle | Per ISO 21649:2006 (for spring life cycle: 20,000) | Successfully completed (20,000 spring life cycle) |
| Performance Profile | Upper and lower acceptance limits (per ISO 21649:2006) | Successfully completed |
| Emitted Noise | Per ISO 21649:2006 | Successfully completed |
| Syringe Robustness | Needle-free Syringe Irradiated Dose Test | Successfully completed |
| Biocompatibility | ISO 10993 standard | Meets requirements for safe short-term exposure |
| Design Controls | In accordance with PharmaJet® SOPs, ISO 13485, ISO 14971, 21 CFR 820.30 | Conducted and prepared |
| Depth of Penetration (IM) | Substantially equivalent or greater than predicate | Greater depth of penetration than predicate (for IM) |
| Depth of Penetration (SC) | Substantially equivalent to predicate | Substantially equivalent to predicate (for SC) |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Tests: No specific sample sizes (n-numbers) are provided for each individual bench test (e.g., how many devices were tested for dose accuracy or life cycle). The document states "The following tests have been successfully completed" without quantification of samples per test.
- Animal Test: The document states "Animal testing was performed... in an animal (pig) model." No specific number of animals (sample size) or injections is specified.
- Data Provenance:
- Bench tests are assumed to be conducted in-house or by a contract lab.
- Animal test data is from an "animal (pig) model," implying a laboratory setting.
- The document does not mention country of origin for the data, but the applicant (PharmaJet®, Inc.) is based in Golden, CO, USA.
- All data described appears to be prospective testing specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A) for this type of submission. This submission is for a physical medical device (needle-free injection system), not an AI/ML diagnostic or prognostic device that relies on expert interpretation of medical images or data for ground truth. Ground truth for this device is based on objective measurements from bench tests, animal studies, and compliance with recognized standards.
4. Adjudication Method for the Test Set
- Not Applicable (N/A) for this type of submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in radiological reads). This device relies on objective physical measurements and functional performance, not subjective expert judgment that requires adjudication.
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 (N/A) for this type of submission. MRMC studies are specific to evaluating the clinical performance of AI/ML algorithms, particularly in diagnostic imaging, by comparing human readers' performance with and without AI assistance. This document describes a physical medical device and its equivalence to a predicate, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A) for this type of submission. This question pertains to AI/ML software performance. The PharmaJet® Stratis Needle-free Injection System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance and safety is established through:
- Objective Measurements: Results from bench tests such as dose accuracy, life cycle, temperature, free-fall, vibration, shock, performance profile, and noise testing, using calibrated equipment and defined protocols based on ISO 21649:2006.
- Animal Study Observations: Data from the pig model for intramuscular and subcutaneous penetration depth. This serves as a proxy for in-vivo performance compared to the predicate.
- Material Science & Biocompatibility Testing: Compliance with ISO 10993 for material safety.
- Compliance with Standards: Meeting the requirements of ISO 21649:2006.
8. The Sample Size for the Training Set
- Not Applicable (N/A) for this type of submission. The concept of a "training set" applies to machine learning algorithms. This document describes the development and testing of a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A) for this type of submission. As there is no AI training set, there is no ground truth established for it.
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JUL 2 7 2011
Special 510(k) Premarket Notification PharmaJet®, Inc. PharmaJet® Stratis Needle-free Injection System
Page 1 of 5
Section 5: 510(k) Summary
| 510(k) Number: | K111517 |
|---|---|
| Date Prepared: | 31 May 2011 |
Device Name - Proprietary, Common, Classification, and Panel
| Proprietary: | PharmaJet® Stratis 0.5 mL Needle-free Injection System |
|---|---|
| Common: | Injector, Fluid, Non-Electrically Powered |
| Classification: | 21 CFR 880.5430; Product Code KZE, Class II |
| Device Panel: | General Hospital |
Application Information
| Applicant: | PharmaJet®, Inc.400 Corporate Circle, Suite NGolden, CO 80401 |
|---|---|
| ------------ | ----------------------------------------------------------------------- |
Telephone: FAX: Establishment Registration: Owner/Operator:
(303) 526-4278 (303) 526-4052 3004977013 9063237
Submission Correspondent Information
Contact: Telephone: Michael J. Ryan, R.A. Manager (303) 526-4278 Ext. 4172
Reason for Premarket Notification
Device modifications
Predicate Device
PharmaJet® 0.5 mL Needle-free Injection System, K081532
Description of the Device
The PharmaJet® Stratis 0.5 mL Needle-free Injection System is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet® System consists of an injector, a reset station, a single use, sterile disposable filling adapter, and a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are
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Special 510(k) Premarket Notification PharmaJet®, Inc. PharmaJet® Stratis Needle-free Injection System Page 2 of 5
used. The components of the PharmaJet® System are unique and cannot be used with any other needle-free system.
The Predicate device, the PharmaJet® 0.5 mL Needle-free Injection system (K081532) is a compact, spring-loaded needle-free hypodermic injection system. The predicate system consists of two (2) injectors; a reset station; a single use, sterile disposable filling adapter; and, a single use, sterile disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet® System are unique and cannot be used with any other needle-free system.
Injectors
The Injector is a reusable compact spring-actuated needle-free hypodermic injector consisting of the body, inner body/safety collar, trigger, and spring.
Needle-free Syringes
The Needle-free syringes are sterile, single use, transparent, disposable containers consisting of: the barrel to hold 0.5 mL of medicine or vaccine; a plunger to discharge the medicine or vaccine through a small diameter orifice at the forward end of the barrel; and, an o-ring on the plunger to prevent leakage of the medicine or vaccine rearward.
Reset Stations
The Reset Station is used to prepare (reset) the spring, located within the injector, for an injection.
Filling Adapters
The Filling Adapter is a sterile, single use, transparent, disposable, accessory that allows the needle-free svringe to be filled from medicine or vaccine storage vials.
Intended Use
The Stratis Needle-free Injection System is intended to deliver subcutaneous or intramuscular injections of vaccines or medicines.
Indications for Use
The PharmaJet® Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet® Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized
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Special 510(k) Premarket Notification PharmaJet®, Inc. PharmaJet® Stratis Needle-free Injection System KIJISI 7 Page 3 of 5
by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.
Technological Characteristics
The technological characteristics of the Stratis System are substantially equivalent to the predicate system and are summarized in the table below.
| Technological Characteristics Summary | ||
|---|---|---|
| Characteristic | PharmaJet® Stratis Needle-free Injection System | PharmaJet® 0.5 ml Needle-free Injection System (K081532) |
| Injector | ||
| Material | Polycarbonate-ABS | Polyetherimide |
| Trigger | Ball/Latch trigger | Latch spring trigger |
| Syringe retainer mechanism | Syringe is pushed into the pawl mechanism | Physical ¼ turn of the syringe |
| Energy source | Stainless SteelCompression spring | Stainless SteelCompression spring |
| Spring life cycle | 20,000 | 20,000 |
| Method of spring reset | External resetting device | External resetting device |
| ISO 21649: 2006 compliant | Yes | Yes |
| Volume | 0.5 mL | 0.5 mL |
| Syringe | ||
| Orifice Diameter | 0.010" | 0.009" |
| Tip Ring Diameter | 0.329" | 0.529" |
| Barrel | Polycarbonate | Polypropylene |
| Plunger | Lustran 348 ABS | Polycarbonate |
| Plunger o-ring | Medical Grade Silicone | Medical Grade Silicone |
| Disposable | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization Method | Gamma radiation | Electron beam radiation |
| Filling Adapter | ||
| Material | Polycarbonate | Polycarbonate |
| O-Ring material | N/A | Medical Grade Silicone |
| Reset Station | ||
| Material | Polycarbonate-ABS | Polyetherimide |
Summary of Non-clinical Bench Tests
The purpose of the Bench Testing for the PharmaJet® Stratis Needle-free Injection System was to establish that the system meets the requirements of the Product and Engineering Specifications with regard to robustness for customer needs and the essential requirements of ISO21649:2006 Needle-free injectors for medical use -Requirements and test methods.
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Special 510(k) Premarket Notification PharmaJet®, Inc. PharmaJet® Stratis Needle-free Injection System
K1151+
Page 4 of 5
The following tests have been successfully completed:
- · Temperature, storage temperature, free-fall, vibration, shock, dose accuracy, life cycle, performance profile upper and lower acceptance limits and emitted noise testing according to ISO 21649: 2006 Needle-free injectors for medical use - Requirements and test methods
- Needle-free Syringe Irradiated Dose Test for Robustness o
Summary of Animal Test
Animal testing was performed to demonstrate substantial equivalence to the predicate device for intramuscular and subcutaneous injections in an animal (pig) model. The test results indicate that the PharmaJet® Stratis Needle-free Injection System has greater depth of penetration than the predicate device for intramuscular injections and is substantial equivalence to the predicate device for subcutaneous injections.
Biocompatibility
Biocompatibility testing demonstrate that the PharmaJet® Needle-free Syringe and Filling Adapter was tested to the ISO 10993 standard and meets the requirements for safe short-term exposure.
Design Control/Risk Analysis/Design Verification & Validation
The design control activities: design inputs, design outputs, risk analysis, and design verification activities for the Stratis Needle-free Injection System have been conducted and prepared in accordance with the applicable PharmaJet® standard operating procedures for design control, ISO 13485, ISO 14971, and 21 CFR 820.30.
Verification and validation testing was formally controlled and included test methods, tests used, and acceptance criteria. Design verification and validation consisted of biocompatibility testing, depth of penetration testing in an ultrasound gel model, and ISO 21649: 2006 Needle-free injector compliance testing. This testing has demonstrated that the design outputs of the device have met the predetermined design input requirements.
Conclusion
The PharmaJet® Stratis Needle-free injection System is of the same inherent technology as the predicate device, the PharmaJet® 0.5 mL Needle-free Injection System. Spring powered injection technology is employed in both the subject and predicate device.
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Special 510(k) Premarket Notification PharmaJet®, Inc. KIIISIT PharmaJet® Stratis Needle-free Injection System Page 5 of 5
The indications for use for the subject device are equivalent to the indications for use for the predicate device.
The performance characteristics of the Stratis Needle-free Injection System are substantially equivalent to the predicate device and have been verified to meet the requirements defined in design inputs as well as ISO 21649: Needle-free injectors - for medical use. Design verification and validation testing has demonstrated the subject device to be substantially equivalent to the predicate device.
Animal test results in a pig model indicate that the PharmaJet® Stratis Needlefree Injection System is substantially equivalent to the PharmaJet® 0.5 mL Needle-free Injection System, K081532.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three wavy lines, which are positioned to the right of the text. The text is arranged in a circular pattern around the graphic, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael J. Ryan Regulatory Affairs Manager PharmaJet, Incorporated 400 Corporate Circle, Suite N Golden, Colorado 80401
JUL 27 2011
- Re: K111517
Trade/Device Name: PharmaJet® Stratis 0.5 mL Needle-free Injection System Regulation Number: 21 CFR 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: July 8, 2011 Received: July 11, 2011
Dear Mr. Ryan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Ryan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ DRHOffices ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
| 510(k) Number (if known): | KITENT |
|---|---|
| Device Name: | PharmaJet®, Inc.,PharmaJet® Stratis Needle-free Injection System |
| Indications for Use: | The PharmaJet® Stratis Needle-free Injection System isintended to deliver various medications and vaccines eitherintramuscularly or subcutaneously by means of a narrow, highvelocity fluid jet, which penetrates the skin and delivers themedicine or vaccine to the body. Healthcare providers whoroutinely administer injections may use the PharmaJet®Needle-free Injection System. It may be used for adults andchildren. It can also be used by patients authorized by theirphysicians to self-inject, or to have other individuals administerinjections of prescribed medication. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 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)
R.A. C.A. 7/26/11
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111517
Page 1 of 1
§ 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).