(58 days)
The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs.
The UltiCare™ Disposable Pen Needles are sterile, single-use, hypodermic single lumen needles designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The UltiCare™ Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare™ Disposable Pen Needles are non-toxic and are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (5/32" to 1/2").
The provided text is a 510(k) summary for a medical device, the UltiCare™ Disposable Pen Needles. This document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical performance testing and comparison of characteristics. It does not describe an AI medical device or a study involving human readers or AI assistance.
Therefore, I cannot provide the information requested in your prompt as it pertains to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for AI models, or training sets, because this document describes a physical medical device (pen needles) and not an AI-powered one.
The document details the following about the UltiCare™ Disposable Pen Needles:
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Acceptance Criteria and Device Performance: The primary acceptance criteria for this device are its compliance with various ISO standards, specifically ISO 11608-2:2012 for needles and ISO 10993-1 for biocompatibility, and meeting the requirements outlined in those standards. The document explicitly states that the device "Meets requirements" for all listed parameters from ISO 11608-2:2012.
Test Parameter Clause no. & requirement of ISO 11608-2:2012 Reported Device Performance Results Materials 4.1 The needle shall be made of tubing materials specified in ISO 9626. Meets requirements Dimensions 4.2 The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. Meets requirements Determination of flow rate through the needle 4.3 The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. Meets requirements Bond between hub and needle tube 4.4 The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. Meets requirements Needle points 4.5 When examined under a magnification of x2,5, needle points shall appear sharp and free from feather edges, burrs and hooks. Meets requirements Freedom from defects 4.6 The needle tube shall fulfill the requirements of ISO 7864, 11.3. Meets requirements Lubrication 4.7 The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube. Meets requirements Dislocation of measuring point at patient end 4.8 Dislocation of the cannula point at the patient end shall be in accordance with ISO 11608-2 Table 2 when tested as per Clause 8 (of ISO 11608-2). Meets requirements Determination of functional compatibility with needle-based injection systems 4.9 Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. Meets requirements Ease of assembly and disassembly 4.10 Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11. Meets requirements Sterility 4.11 The needle in its unit packaging shall has been subjected to a validated sterilization process. Meets requirements Pre-conditioning of needles 6 All requirements of the standard related to preconditioning of needles were met Meets requirements Biocompatibility Testing per ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Subacute/subchronic toxicity) Did not show any adverse biological/biocompatibility reactions. The document concludes that "UltiCare Disposable Pen Needles successfully passed all the required non-clinical testing."
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Sample size and data provenance: Not applicable in the context of an AI study. The tests apply to the design and manufacturing of the physical pen needles.
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Number of experts and qualifications: Not applicable for establishing ground truth as this is a physical device measured against engineering and biological standards, not an AI model requiring human interpretation of data. The "expertise" lies in the adherence to ISO standards and good manufacturing practices.
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Adjudication method: Not applicable.
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MRMC Comparative Effectiveness Study: Not applicable. Clinical data was stated as "not required" for this device.
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Standalone Performance: The performance described is the standalone performance of the physical device according to specified international standards.
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Type of Ground Truth: The ground truth for this device is based on international standards (ISO 11608-2:2012, ISO 10993-1, USP <788>) and engineering specifications (e.g., specific dimensions, material properties).
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Sample size for training set: Not applicable as this is not an AI/machine learning device.
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How ground truth for training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2021
UltiMed Incorporated % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213407
Trade/Device Name: UltiCare Disposable Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: October 18, 2021 Received: October 19, 2021
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K213407
Device Name UltiCare™ Disposable Pen Needles
Indications for Use (Describe)
The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | UltiMed Inc.350 Highway 7, Suite 100Excelsior, MN 55331 |
|---|---|
| Contact Person: | Cori RaganPrincipal AdvisorLabcorp5353 Wayzata Boulevard, Suite 505Minneapolis, Minnesota 55416Telephone: 612-268-8746Cori.Ragan@labcorp.com |
| Date of Summary: | 15 December 2021 |
| Device Trade Name: | UltiCare™ Disposable Pen Needles |
| Common or Usual Name: | Pen Needles |
| Regulation Number: | 21 CFR §880.5570 |
| Classification Name: | Hypodermic single lumen needles |
| Product Code: | FMI |
| Device Classification: | II |
| Review Panel: | General Hospital |
| Predicate/ ReferenceDevice(s): | Predicate Device - K162516 - BD pen needlesReference Device - K100812 - UltiCare™ Disposable PenNeedles |
| Model Numbers: | 71006 (29G, 12.7mm)61005 (30G, 5mm)61008 (30G, 8mm)71013 (31G, 5mm)71004 (31G, 6mm)71005 (31G, 8mm)71003 (32G, 4mm)71014 (32G, 6mm) |
| Device Description: | The UltiCare™ Disposable Pen Needles are sterile, single-use, hypodermic single lumen needles designed for use withpen injectors for subcutaneous injection of a desired dose ofdrugs approved for delivery using a pen needle. TheUltiCare™ Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needleprimary container. The UltiCare™ Disposable Pen Needlesare non-toxic and are available in a variety of needle sizes(29 gauge to 32 gauge) and lengths (5/32" to 1/2"). |
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The UltiCare™ Disposable Pen Needles are used with pen Intended Use: injector devices for the subcutaneous injection of drugs.
Technological A comparison of characteristics of UltiCare Disposable Pen Characteristics: Needles and the predicate device is shown in the table below.
| Feature | UltiCare™ Disposable PenNeedle (Pending) | BD Pen Needle(K162516) | Conclusion |
|---|---|---|---|
| Product Code | FMI | FMI | Identical |
| DeviceDescription | Pen needle | Pen needle | Identical |
| Design Needleand Hub | Image: UltiCare Disposable Pen Needle | Image: BD Pen Needle | Similar |
| Intended use(s) | The UltiCare™ DisposablePen Needles are used withpen injector devices for thesubcutaneous injection ofdrugs. | BD Pen Needle is intended foruse with pen injector devicesfor the subcutaneous injectionof drugs. | Identical |
| Type of use | Over-the Counter Use | Over-the Counter Use | Identical |
| Specific druguse | Drugs | Drugs | Identical |
| Tip type | Center tip | Center tip | Identical |
| Needle lumen | Single Lumen | Single Lumen | Identical |
| Needle gauge(mm) | 32 G (0.23 mm)to29 G (0.33 mm) | 32 G (0.23 mm)to29 G (0.33 mm) | Identical |
| Needle length ininches (mm) | 5/32" (4 mm)to1/2" (12.7 mm) | 5/32" (4 mm)to1/2" (12.7 mm) | Identical |
| Needleconnector type | Compatible with pen injectorsthat comply with ISO 11608-1 | Compatible with pen injectorsthat comply with ISO 11608-1 | Identical |
| Biocompatibility | Conforms to ISO10993-1 | Conforms to ISO10993-1 | Identical |
| Sterilization | Ethylene Oxide (EtO) | Gamma Irradiation | Different |
Table 5-1: Characteristic Comparison
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| Feature | UltiCare™ Disposable PenNeedle (Pending) | BD Pen Needle(K162516) | Conclusion |
|---|---|---|---|
| Method ofattachment topen injector | Screw threads | Screw threads | Identical |
| Sterility | $SAL = 10^{-6}$ | $SAL = 10^{-6}$ | Identical |
| Needle | Stainless Steel 304 | Stainless Steel | Identical |
| Needle cover(primarycontainer) | High-Density polyethylene | Unknown | Unknown |
Purpose of the reference device:
The design of the needle and hub as well as the needle cover (primary container) materials and dimensions of the subject device were leveraged from the reference device. All test methods used on the reference device for biocompatibility, performance, shelf life, sterilization, distribution, and package integrity were leveraged for the subject device.
Non-Clinical Performance Data:
UltiCare Disposable Pen Needles successfully passed all the required non-clinical testing which included the following:
- Testing to evaluate particulates per USP <788> .
- Testing for compliance with the requirements of 11608-2:2012 Needle-based . injection systems for medical use -- Requirements and test methods -- Part 2: Needles
- The table below presents the requirements of the 11608-2:2012 Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles standard and the result of the testing conducted.
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| Table 5-2: Requirements of 11608-2:2012 | ||
|---|---|---|
| Test Parameter | Clause no. & requirement of ISO 11608-2:2012 | Results |
| Materials | 4.1 The needle shall be made of tubing materials specified in ISO 9626. | Meets requirements |
| Dimensions | 4.2 The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. | Meets requirements |
| Determination of flow rate through the needle | 4.3 The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. | Meets requirements |
| Bond between hub and needle tube | 4.4 The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Meets requirements |
| Needle points | 4.5 When examined under a magnification of x2,5, needle points shall appear sharp and free from feather edges, burrs and hooks. | Meets requirements |
| Freedom from defects | 4.6 The needle tube shall fulfill the requirements of ISO 7864, 11.3. | Meets requirements |
| Lubrication | 4.7 The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube. | Meets requirements |
| Dislocation of measuring point at patient end | 4.8 Dislocation of the cannula point at the patient end shall be in accordance with ISO 11608-2 Table 2 when tested as per Clause 8 (of ISO 11608-2). | Meets requirements |
| Determination of functional compatibility with needle-based injection systems | 4.9 Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11. | Meets requirements |
| Ease of assembly and disassembly | 4.10 Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11. | Meets requirements |
| Sterility | 4.11 The needle in its unit packaging shall has been subjected to a validated sterilization process. | Meets requirements |
| Pre-conditioning of needles | 6 All requirements of the standard related to preconditioning of needles were met | Meets requirements |
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| Biocompatibilitytesting: | The Biological Tests selected to be performed on the sterile finalproduct that has direct contact with the end-user according to the2020 FDA guidance Use of International Standard ISO 10993- 1,"Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" considering contacttype and duration were as follows:1. Cytotoxicity2. Sensitization3. Irritation or Intracutaneous Reactivity4. Acute Systemic Toxicity5. Material-Mediated Pyrogenicity6. Hemocompatibility7. Subacute/subchronic toxicityBiocompatibility tests selected as per the requirements of FDAguidance Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process" considering contact type andduration for the UltiCare Disposable Pen Needles did not showany adverse biological / biocompatibility reactions. |
|---|---|
| Clinical PerformanceData: | Clinical data is not required. |
| Conclusion: | Testing has demonstrated that UltiCare Disposable PenNeedles are substantially equivalent to the predicate device. |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).