Profoject™ Pen Needles (Model A; Model B)
Device Facts
| Record ID | K260739 |
|---|---|
| Device Name | Profoject™ Pen Needles (Model A; Model B) |
| Applicant | CMT Health PTE., Ltd. |
| Product Code | FMI · General Hospital |
| Decision Date | Jul 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Profoject™ Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Device Story
Profoject™ Pen Needles are sterile, single-use, double-ended needles designed for attachment to pen injector devices via screw threads. The device consists of a stainless steel needle tube, plastic hub, needle shield, container, and sealed paper. It is operated manually by the user to deliver subcutaneous injections. The device is intended for use in clinical or home settings. The needle container and sealed paper maintain sterility until the point of use. The device facilitates drug delivery by providing a fluid path from the pen injector to the patient's subcutaneous tissue.
Clinical Evidence
Bench testing only. No clinical data provided. Performance verified via ISO 11608-2:2022, ISO 9626, and biocompatibility testing per ISO 10993-1:2018. Packaging integrity validated via ASTM standards (F1886, F88, F1929, F1140). Sterility and endotoxin levels confirmed via USP <71>, <85>, and <788>.
Technological Characteristics
Materials: 304 stainless steel needle tube, polypropylene hub/container, HDPE/PP shield, dialysis paper seal, polydimethylsiloxane lubricant. Dimensions: 28G-34G gauges, 4mm-12mm lengths. Wall types: Regular (RW) and Thin (TW). Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Connectivity: None (mechanical).
Indications for Use
Indicated for patients requiring subcutaneous injection of drugs using pen injector devices.
Regulatory Classification
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.
Predicate Devices
- Droplet® Pen Needles (K171982)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
July 15, 2026
CMT Health PTE., Ltd.
Monica Ma
Official Correspondent
150 Beach Road., #28-05, Gateway West
Singapore, 189720
Singapore
Re: K260739
Trade/Device Name: Profoject™ Pen Needles (Model A; Model B)
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: FMI
Dated: June 16, 2026
Received: June 16, 2026
Dear Monica Ma:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260739 - Monica Ma
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Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K260739 - Monica Ma
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Sincerely,
SHRUTI N. MISTRY -S
Shruti Mistry
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
*See PRA Statement below.*
510(k) Number (*if known*)
K260739
Device Name
Profoject™ Pen Needles (Model A; Model B)
Indications for Use (*Describe*)
Profoject™ Pen Needles are intended for use 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)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
# 510(k) Summary
# 1. Submission Information
| 510(k) Number: | K260739 |
| --- | --- |
| Date of submission: | March 6, 2026 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter: | CMT HEALTH PTE. LTD.150 BEACH ROAD, #28-05, GATEWAY WEST,SINGAPORE, 189720Contact Person: Monica MaE-mail: Ra@cmthealth.comTel: +6568461379 |
# 2. Device Description
Trade Name: Profoject™ Pen Needles (Model A; Model B)
Regulation Name: Hypodermic Single Lumen Needle
Device Class: II
Product Code: FMI
Regulation Number: 21 CFR 880.5570
Review Panel: General Hospital
Indications for Use: Profoject™ Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
Profoject™ Pen Needles are available in two models, Model A and Model B, which share identical components and differ only in dimensional specifications. Both models are supplied sterile and are intended for single-use only. The two models have identical structural composition and consist of the following five components: (1) Needle Container, (2) Needle Shield, (3) Needle Tube, (4) Needle Hub, and (5) Sealed Paper. The Needle Container, together with the Sealed Paper, forms the unit packaging of the Profoject™ Pen Needles and maintains the sterility of the product until use. The Needle Hub is designed to be screwed onto compatible pen injectors.
The specifications are as follows.
Table 1 Specifications for Profoject™ Pen Needles (Model A)
| Specifications | | Color of Needle Shield | Specifications | | Color of Needle Shield |
| --- | --- | --- | --- | --- | --- |
| 1 | 0.18mm(34G)×4mm TW | Brown | 13 | 0.25mm(31G)×8mm TW | Orange |
| 2 | 0.20mm(33G)×4mm TW | Pink | 14 | 0.30mm(30G)×4mm TW | Deep Purple |
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510(k) Summary
| 3 | 0.20mm(33G)×5mm TW | Warm gray | 15 | 0.30mm(30G)×5mm TW | Red |
| --- | --- | --- | --- | --- | --- |
| 4 | 0.20mm(33G)×6mm TW | Brown | 16 | 0.30mm(30G)×6mm TW | Black |
| 5 | 0.20mm(33G)×8mm TW | Cream | 17 | 0.30mm(30G)×8mm TW | Yellow |
| 6 | 0.23mm(32G)×4mm TW | Light green | 18 | 0.30mm(30G)×10mm TW | Deep green |
| 7 | 0.23mm(32G)×5mm TW | gray | 19 | 0.33mm(29G)×4mm TW | Deep red |
| 8 | 0.23mm(32G)×6mm TW | Pale Brown | 20 | 0.33mm(29G)×5mm TW | White |
| 9 | 0.23mm(32G)×8mm TW | Blue-green | 21 | 0.33mm(29G)×8mm TW | Brown |
| 10 | 0.25mm(31G)×4mm TW | Light blue | 22 | 0.33mm(29G)×10mm TW | Light purple |
| 11 | 0.25mm(31G)×5mm TW | Purple | 23 | 0.33mm(29G)×12mm TW | Red |
| 12 | 0.25mm(31G)×6mm TW | Deep blue | / | / | / |
Table 2 Specifications for Profoject™ Pen Needles (Model B)
| Specifications | | Color of Needle Shield | Specifications | | Color of Needle Shield |
| --- | --- | --- | --- | --- | --- |
| 1 | 0.18mm(34G)×4mm RW | Brown | 30 | 0.30mm(30G)×4mm TW | Deep Purple |
| 2 | 0.18mm(34G)×4mm TW | Brown | 31 | 0.30mm(30G)×5mm RW | Red |
| 3 | 0.18mm(34G)×5mm RW | Magenta | 32 | 0.30mm(30G)×5mm TW | Red |
| 4 | 0.18mm(34G)×5mm TW | Magenta | 33 | 0.30mm(30G)×6mm RW | Black |
| 5 | 0.20mm(33G)×4mm RW | Pink | 34 | 0.30mm(30G)×6mm TW | Black |
| 6 | 0.20mm(33G)×4mm TW | Pink | 35 | 0.30mm(30G)×8mm RW | Yellow |
| 7 | 0.20mm(33G)×5mm RW | Warm gray | 36 | 0.30mm(30G)×8mm TW | Yellow |
| 8 | 0.20mm(33G)×5mm TW | Warm gray | 37 | 0.30mm(30G)×10mm RW | Deep green |
| 9 | 0.20mm(33G)×6mm RW | Brown | 38 | 0.30mm(30G)×10mm TW | Deep green |
| 10 | 0.20mm(33G)×6mm TW | Brown | 39 | 0.33mm(29G)×4mm RW | Deep red |
| 11 | 0.20mm(33G)×8mm RW | Cream | 40 | 0.33mm(29G)×4mm TW | Deep red |
| 12 | 0.20mm(33G)×8mm TW | Cream | 41 | 0.33mm(29G)×5mm RW | White |
| 13 | 0.23mm(32G)×4mm RW | Light green | 42 | 0.33mm(29G)×5mm TW | White |
| 14 | 0.23mm(32G)×4mm TW | Light green | 43 | 0.33mm(29G)×6mm RW | Blue-gray |
| 15 | 0.23mm(32G)×5mm RW | gray | 44 | 0.33mm(29G)×6mm TW | Blue-gray |
| 16 | 0.23mm(32G)×5mm TW | gray | 45 | 0.33mm(29G)×8mm RW | Brown |
| 17 | 0.23mm(32G)×6mm RW | Pale Brown | 46 | 0.33mm(29G)×8mm TW | Brown |
| 18 | 0.23mm(32G)×6mm TW | Pale Brown | 47 | 0.33mm(29G)×10mm RW | Light purple |
| 19 | 0.23mm(32G)×8mm RW | Blue-green | 48 | 0.33mm(29G)×10mm TW | Light purple |
| 20 | 0.23mm(32G)×8mm TW | Blue-green | 49 | 0.33mm(29G)×12mm RW | Red |
| 21 | 0.25mm(31G)×4mm RW | Light blue | 50 | 0.33mm(29G)×12mm TW | Red |
| 22 | 0.25mm(31G)×4mm TW | Light blue | 51 | 0.36mm(28G)×4mm RW | Cool Gray |
| 23 | 0.25mm(31G)×5mm RW | Purple | 52 | 0.36mm(28G)×4mm TW | Cool Gray |
| 24 | 0.25mm(31G)×5mm TW | Purple | 53 | 0.36mm(28G)×5mm RW | Green-yellow |
| 25 | 0.25mm(31G)×6mm RW | Deep blue | 54 | 0.36mm(28G)×5mm TW | Green-yellow |
| 26 | 0.25mm(31G)×6mm TW | Deep blue | 55 | 0.36mm(28G)×6mm RW | Olive green |
| 27 | 0.25mm(31G)×8mm RW | Orange | 56 | 0.36mm(28G)×6mm TW | Olive green |
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510(k) Summary
| 28 | 0.25mm(31G)×8mm TW | Orange | 57 | 0.36mm(28G)×8mm RW | Cobalt blue |
| --- | --- | --- | --- | --- | --- |
| 29 | 0.30mm(30G)×4mm RW | Deep Purple | 58 | 0.36mm(28G)×8mm TW | Cobalt blue |
### 3. Identification of Predicate Device
Predicate Device
510(k) Number: K171982
Product Name: Droplet® Pen Needles
### 4. Substantially Equivalent Comparison
| Parameters | | Proposed Device | Predicate Device | Remark |
| --- | --- | --- | --- | --- |
| 1 | 510(k) Number | K260739 | K171982 | / |
| 2 | 510(k) Holder | CMT HEALTH PTE. LTD. | HTL-STREFA S.A. | / |
| 3 | Trade Name | Profoject™ Pen Needles | Droplet® Pen Needles | / |
| 4 | Product code | FMI | FMI | Same |
| 5 | Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| 6 | Classification Name | Hypodermic Single Lumen Needle | Hypodermic Single Lumen Needle | Same |
| 7 | Regulation Class | II | II | Same |
| 8 | Indications for use | Profoject™ Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs. | Droplet® Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs. | Same |
| 9 | Prescription/OTC | OTC | OTC | Same |
| 10 | Supplied sterile | Yes | Yes | Same |
| 11 | Single use | Yes | Yes | Same |
| 12 | Principle of operation | Manual | Manual | Same |
| 13 | Method of attachment to pen injector | Screw threads | Screw threads | Same |
| 14 | Models | Model A Length: 4mm, 5mm, 6mm, 8mm, 10mm, 12mm Gauge: 29G, 30G, 31G, 32G, 33G, 34G Model B Length: 4mm, 5mm, 6mm, 8mm, 10mm, 12mm | Length: 4mm, 5mm, 6mm, 8mm, 10mm, 12mm Gauge: 29G, 31G, 32G | Different See discussion 1 |
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510(k) Summary
| | | Gauge: 28G, 29G, 30G, 31G, 32G, 33G, 34G | | |
| --- | --- | --- | --- | --- |
| 15 | Wall types | Regular wall (RW), Thin wall (TW) | Not disclosed | Different See discussion 2 |
| 16 | Biocompatibility | Conform with ISO 10993 standards | Conform with ISO 10993 standards | Same |
| 17 | Sterility | SAL=10^{-6} | SAL=10^{-6} | Same |
| 18 | Sterilization method | EO sterilized | Gamma irradiation | Different See discussion 3 |
| 19 | Shelf Life | 5 years | 5 years | Same |
| 20 | Unit Packaging | 1) Polypropylene 2) Needle container with seal made of dialysis paper | 1) Polypropylene 2) container with seal made of medical grade paper | Different See discussion 4 |
| 21 | Material | 1) Needle Tube: 304 Stainless steel 2) Needle Hub and Needle Container: Polypropylene 3) Needle Shield: High Density Polyethylene/Polypropylene 4) Sealed Paper: Dialysis paper 5) Needle point lubricant: Polydimethylsiloxanes | 1) Needle Tube: Medical Grade Stainless Steel 2) Needle Hub, Needle Container, Needle Shield: Plastic resins 3) Lubricant: Medical grade silicone | Different See discussion 5 |
| 22 | Configuration | 1) Needle Tube 2) Needle Hub 3) Needle Container 4) Needle Shield 5) Sealed Paper | 1) Needle Tube 2) Needle Hub 3) Needle Container 4) Needle Shield | Different See discussion 6 |
| 23 | Performance Testing | Complied with: ISO 11608-2:2022 ISO 9626 | Complied with: ISO 11608-2:2012 ISO 9626 ISO 7864 | Different See discussion 7 |
### Discussion in details:
#### Discussion 1 - Models
The models of proposed devices are different from the predicate device. However, this difference is just in dimension. Different gauges, length and wall of needle tube will be selected by physician per patient's condition. This difference does not affect intended use. In addition, bench performance tests were conducted on the proposed device and the results met the requirements in the standards. Therefore, the differences in models do not raise different questions of safety and effectiveness when compared to the predicate device.
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510(k) Summary
# Discussion 2 - Wall types
The needle wall types of proposed device include regular wall and thin wall, while the wall types of the predicate device are not disclosed in public documents. However, this difference is just in wall thickness. This difference does not affect intended use. In addition, bench performance tests were conducted on the proposed device and the results met the requirements in the standards. Therefore, the differences in wall types do not raise different questions of safety and effectiveness when compared to the predicate device.
# Discussion 3 - Sterilization method
The sterilization method of proposed device is EO, the sterilization method of predicate device is gamma irradiation. Both achieve a Sterility Assurance Level (SAL) of 10⁻⁶. Examination of the EO and ECH residuals have met with prolonged exposure devices allowable limits of ISO 10993-7 AMD 1:2019, this sterilization method difference does not raise different questions of safety and effectiveness when compared to the predicate device.
# Discussion 4 - Unit Packaging
The sealing material of the proposed device is dialysis paper, which is a commonly used material in sterile barrier systems for single-use medical devices. The dialysis paper has been validated through manufacturing process validation and demonstrated the performance in terms of microbial barrier and breathability. It meets the requirements of ISO 11607 and ensures compatibility with the sterilization process. In addition, packaging integrity and sterility tests have been conducted. Therefore, the use of this material does not raise different questions of safety and effectiveness when compared to the predicate device.
# Discussion 5 - Material
There are differences between the materials of the proposed device and those of the predicate device. However, the proposed devices demonstrated that they complied with ISO 10993 series standards. In addition, bench performance tests were conducted on the proposed device and the results met the requirements in the standards. Therefore, the difference on material does not raise different questions of safety and effectiveness when compared to the predicate device.
# Discussion 6 - Configuration
The only configuration difference between the proposed device and the predicate device is the presence of a sealed paper in the proposed device. The sealed paper is only used as a packaging component to maintain sterility prior to use and is removed before the device is applied. This difference does not change the intended use of the device and does not affect its performance or biocompatibility. Therefore, the difference in configuration does not raise different questions of safety and effectiveness when compared to the predicate device.
# Discussion 7 - Performance Testing
The predicate device was evaluated according to ISO 11608-2:2012, which required compliance with ISO 7864:1993 for the “freedom-from-defects” criterion. The proposed device was evaluated in
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510(k) Summary
accordance with the updated ISO 11608-2:2022, where this requirement is incorporated directly under Clause 5.2.5 without reference to ISO 7864.
Although different versions of ISO 11608-2 were applied, both include equivalent “freedom-from-defects” criteria. The proposed device follows the updated and consolidated version of the standard, and this difference does not raise different questions of safety and effectiveness when compared to the predicate device.
# 5. Substantial Equivalent Based on Assessment of Clinical Performance Data
Not applicable.
# 6. Non-Clinical Test
Non-clinical verification of the Profoject™ Pen Needles have been conducted to evaluate their safety, performance, and functionality. The results of these tests have demonstrated the overall safety of the proposed device and its effectiveness in accordance with relevant test methods, and ultimately support a substantial equivalence determination. Particularly, the following was conducted to adequately demonstrate the effectiveness of the proposed device in accordance with relevant test methods cited below:
● Performance Testing
1) ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.
2) ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended Pen Needles.
3) ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
4) ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials.
5) ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
6) ASTM F1140/F1140M - 13 (2020) e1 Standard test methods for internal pressurization failure resistance of unrestrained packages.
7) ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
8) ISTA 3A: 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less.
9) ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)].
10) USP - NF <788> Particulate Matter in Injections.
11) USP - NF <85> Bacterial Endotoxin Testing.
12) USP - NF <71> Sterility Tests.
● Biocompatibility Testing
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510(k) Summary
The biocompatibility evaluation for the Profoject™ Pen Needles were conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1. Evaluation and Testing within a Risk Management Process, as recognized by FDA. The proposed device is classified as an externally communicating with prolonged, blood path indirect contact.
1) ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
2) ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
3) ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
4) USP <151> Rabbit Pyrogen Study
5) ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
6) ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
7) ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
# Conclusion:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Profoject™ Pen Needles are substantially equivalent to the predicate device Droplet® Pen Needles with respect to the indications for use, target population, treatment method, and technological characteristics.
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