(150 days)
The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½".
The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature.
The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
The provided text describes a Special 510(k) Summary for the 1mL Unitract® Insulin Syringe. It outlines the device's characteristics, indications for use, and a summary of performance tests conducted to establish substantial equivalence to a predicate device.
However, the document does not provide the detailed acceptance criteria or the specific results of a study in a tabular format as requested. Instead, it offers a general statement about mechanical performance, chemical testing, biocompatibility testing, and sterilization validation.
Therefore, I cannot fully complete the requested table or answer all direct questions about study specifics (like sample sizes, ground truth establishment, or expert involvement) as this information is not present in the provided text.
Here is an attempt to structure the available information regarding acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets design specifications based on the requirements of the FDA Consensus Standard and voluntary standards. This would encompass aspects like plunger force, needle security, leak prevention, etc., though specific numerical criteria are not detailed. | "Mechanical performance tests were conducted to verify the device meets design specifications based on the requirements of the FDA Consensus Standard and the voluntary standards." (General statement of compliance, no specific values or thresholds reported). |
| Safety Features | Specific criteria for peak activation forces of the retraction mechanism, spring reaction forces, and forces to override the auto-disable feature. (Specific numerical criteria are not detailed). | "Additional performance testing was conducted on the safety features relating to peak activation forces of the retraction mechanism, spring reaction forces and forces to override the auto disable feature." (General statement of testing, no specific values or thresholds reported, but implies these aspects were evaluated and found acceptable). |
| Biocompatibility | Materials in the fluid path meet USP Class VI requirements. Cytotoxicity and pyrogenicity levels must be acceptable. | "Biocompatibility testing of the finished devices included Cytotoxicity and Pyrogens; with all materials in the fluid path meeting USP Class VI requirements." (All materials met USP Class VI, suggesting acceptable cytotoxicity and pyrogenicity). |
| Chemical Residues | Acceptable levels for Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH, and chemical residues (EO Sterilization). (Specific numerical criteria are not detailed). | "Chemical testing included Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues (EO Sterilisation)." (General statement of testing, no specific values or thresholds reported, but implies these aspects were evaluated and found acceptable). |
| Sterilization Assurance | Sterilization processes validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to achieve a sterility assurance level (SAL) of 10⁻⁶. | "Sterilisation processes are validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to a sterility assurance level (SAL) of 10⁻⁶." (Successfully validated to the specified standard and SAL). |
| Manufacturing Control | Functional, chemical, and biological tests performed on each production lot number. | "Manufacturing process control requires functional, chemical and biological tests be performed on each production lot number." (Indicates adherence to process controls throughout manufacturing). |
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: Not specified in the provided text for any of the performance tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were conducted internally by Unilife Medical Solutions Limited, based in Lewisberry, PA, USA.
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 type of information is generally not applicable to the performance testing of a physical medical device like a syringe, which relies on objective measurements against engineering and biological standards, rather than expert interpretation of data like in an AI/imaging study. No experts are mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; adjudication methods are typically used for subjective assessments (e.g., in clinical trials or AI studies) where consensus among experts is needed for ground truth. The tests described are objective, physical, chemical, and biological measurements.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI-assisted diagnostic tools, not to the performance validation of a medical syringe. The device described does not involve "human readers" interpreting data or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This concept is relevant to AI algorithms, which is not what this submission is about. The device is a physical syringe, and its performance is evaluated through material, mechanical, and biological testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance tests would be defined by established engineering standards, FDA Consensus Standards, voluntary industry standards (e.g., DIN EN 550:1994 for sterilization), and USP Class VI requirements for biocompatibility. For mechanical tests, the "ground truth" is whether the device meets specified force, dimension, or functional parameters. For chemical and biological tests, it's whether results fall within acceptable limits defined by regulatory and material science standards.
8. The sample size for the training set
- Not applicable. The submission describes a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo for Unilife medical solutions. The word "UNILIFE" is in bold, sans-serif font, with the words "medical solutions" in a smaller font below. Above the logo is the number "2093400" written in cursive. To the right of the word "UNILIFE" is a square logo with a black and white design.
SECTION 6
Special 510(k) Summary
APR - 1 2010
This 510(k) summary has been prepared in compliance with 21 CFR 807.92.
| Applicant: | Unilife Medical Solutions Limited633 Lowther RdLewisberry, PA 17339Tel: 717-938-9323Fax: 717-938-9364 |
|---|---|
| Contact: | Melissa L. DeHass, Senior Manager, Regulatory AffairsEmail: Melissa.dehass@unilife.com |
| Date Prepared: | 30 October 2009 |
| Trade Name: | 1mL Unitract® Insulin Syringe |
| Common Name: | Piston Syringe |
| Classification: | Syringe, Piston; 21 CFR 880.5860; FMF; Class II |
| Predicate Devices: | Unitract Insulin Syringe (K080877) |
| Device Description: | The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, singleuse, syringe, consisting of a barrel and plunger assembly. Thesyringe is supplied in two needle sizes, being 27G x ½" and 29G x½".The devices function in a manner similar to standard syringes forfilling and mixing insulin and subcutaneous injection, but alsoincorporates a sharps injury prevention (automatic needle retraction)and reuse prevention (auto disable) feature.The syringe, as supplied, is a device with a small barrel, plunger andfixed needle, calibrated in units of insulin (U-100), to be used toadminister (infuse) insulin subcutaneously. It incorporates featuresthat include reuse prevention and sharps injury prevention.The sharps injury prevention feature allows for automatic and fullretraction of the needle into the syringe barrel immediately after thefull dose has been expelled; where the rate of retraction may becontrolled by the user. The reuse prevention feature also engagesimmediately after retraction, which prevents further movement ofthe plunger in either direction. |
| Indications for Use: | The syringe, as supplied, is a device with a small barrel, plunger andfixed needle, calibrated in units of insulin (U-100), to be used toadminister (infuse) insulin subcutaneously. It incorporates featuresthat include reuse prevention and sharps injury prevention. |
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Image /page/1/Picture/0 description: The image shows the logo for UNILIFE medical solutions. The word "UNILIFE" is written in a stylized font, with the letters connected to each other. Below the word "UNILIFE" is the phrase "medical solutions" in a smaller font. To the right of the word "UNILIFE" is a graphic that looks like a backwards "L" shape.
Substantial Equivalence:
The 1mL Unitract® Insulin Syringe has identical indications for use to the cited predicate # K080877 which is to infuse drugs; whilst incorporating a sharps injury prevention feature. The device design and technology is identical to K080877. The label changes to the 1mL Unitract® Insulin Syringe do not raise new questions of safety and effectiveness based on its similarities to the cited predicates in terms of design and intended use.
The ImL Unitract® Insulin Syringe has identical needle retraction mechanisms to the cited predicate # K080877. The syringe is filled; and at the end of the injection stroke once the full dose has been expelled, the plunger engages the needle to allow retraction into the syringe barrel. The auto disable feature of the 1mL Unitract® Insulin Syringe is integrated within the plunger design, where after full retraction, the plunger engages with the collar outer to prevent movement of the plunger in either direction. This feature requires no secondary action by the user to disable the syringe.
The characteristics of the 1mL Unitract® Insulin Syringe spring based mechanism are identical to the technology of the cited predicate # K080877. The 1mL Unitract® Insulin Syringe spring mechanism is located on the proximal end of the syringe to allow retraction into the barrel.
The design of the 1mL Unitract® Insulin Syringe integrates the technological design characteristics of the cited predicate, and having identical operating procedures for aspiration and injection, has been demonstrated to have no significant differences.
The syringe components are manufactured from biocompatible materials and stainless steel.
Mechanical performance tests were conducted to verify the device meets design specifications based on the requirements of the FDA Consensus Standard and the voluntary standards.
Additional performance testing was conducted on the safety features relating to peak activation forces of the retraction mechanism, spring reaction forces and forces to override the auto disable feature.
Chemical testing included Reducing (Oxidisable) Matter, Extractable Trace Metals, Non-Volatile Residue, pH and chemical residues (EO Sterilisation).
Biocompatibility testing of the finished devices included Cytotoxicity and Pyrogens; with all materials in the fluid path meeting USP Class VI requirements.
Sterilisation processes are validated to European Standard DIN EN 550:1994, Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation to a sterility assurance level (SAL) of 10°.
Manufacturing process control requires functional, chemical and biological tests be performed on each production lot number.
The 1mL Unitract® Insulin Syringe with 27G x 1/2" or 29G x 1/2" needle submitted in this 510(k) is determined as substantially equivalent to the cited predicate devices based on performance testing, intended use and design principles of operation and technology, used for the subcutaneous infusion of insulin. Any
Characteristics:
Technological
Non Clinical Performance Data:
Conclusion:
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Image /page/2/Picture/0 description: The image shows the logo for Unilife medical solutions. The word "UNILIFE" is in bold, sans-serif font. Below the word "UNILIFE" is the phrase "medical solutions" in a smaller font. To the right of the word "UNILIFE" is a graphic of a curved line.
differences cited do not raise any new questions of safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Melissa L. DeHass Senior Manager, Regulatory Affairs Unilife Medical Solutions Limited 633 Lowther Road Lewisberry, Pennsylvania 17339
APR - 1 2010
Re: K093400
Trade/Device Name: 1mL Unitract® Insulin Syringe Regulation Number: 21CFR 880.8560 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 3, 2010 Received: March 4, 2010
Dear Ms. DeHass:
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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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 (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.
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/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Th for
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
Enclosure
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SECTION 5
Indications for Use
510(k) Number (if known):
1mL Unitract® Insulin Syringe Device Name:
Indications for Use:
The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number. K093400
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).