(111 days)
No
The device description and performance studies focus on mechanical function and safety features, with no mention of AI or ML.
No
The device is a syringe intended for the delivery of insulin or tuberculin, and its safety feature guards against needle-sticks, which are delivery and safety functions, not therapeutic ones.
No
Explanation: The device is described as being for "the delivery of U-100 insulin" and "the delivery of tuberculin," which are therapeutic/delivery functions, not diagnostic ones. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description clearly outlines physical components like a syringe barrel, needle, plunger, and safety shield, and describes its function through mechanical action. There is no mention of software as a component or mechanism of action.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of substances (insulin and tuberculin) into the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details a syringe with a needle and a safety feature. This is a device for administering substances, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological specimens, such as reagents, test strips, or analytical processes.
The device is clearly described as a syringe for injection, with a safety feature to prevent needle sticks. This falls under the category of medical devices used for drug delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Product codes (comma separated list FDA assigned to the subject device)
FMF, MEG
Device Description
The Medline Safety Insulin Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for delivery of U-100 Insulin. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver insulin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense insulin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The Medline Safety Insulin Syringe barrel contains major and minor graduated ink markings and will be available in a 1 ml (100 units), and 0.5 ml (50 units) syringe volumes with three different needle gauge sizes.
The Medline TB Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for Tuberculin use. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver tuberculin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense tuberculin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The syringe barrel contains graduated markings, with major graduation markings every 0.05mL and minor graduation markings every 0.01mL. The Medline TB Syringe will be available in a 1 mL syringe volume with three different needle sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical verification of the Medline Safety Insulin and TB Syringes has been conducted to evaluate its 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:
Chemical Safety Testing:
- Particulate Matter Testing in accordance with USP Particulate Matter in Injections
- Phthalate Testing
- Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP Bacterial Endotoxin Testing
Functional Performance Testing:
- Visual Appearance Testing in accordance with ASTM F1886:2016 Standard Test Method For Determining Integrity Of Seals For Flexible Packaging By Visual Inspection
- Package Integrity Testing in accordance with ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- Seal Strength Testing in accordance with ASTM F88-21 Test Method for Seal Strength of Flexible Barrier Materials
- ISO 8537:2016 Sterile Single-Use Syringes, With or Without Needles, for Insulin
- ISO 23908:2011 Sharps Injury Protection Requirements and Test Methods Sharps Protection Features for Single Use Hypodermic Needles, Introducers for Catheters and Needles Uses for Blood Sampling
- ISO 7864:2016 Sterile Hypodermic Needles for Single Use Requirements and Test Methods
- ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacturing of Medical Devices -Requirements and Test Methods
- ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use
Usability Testing:
In accordance with the FDA guidance document Medical Devices with Sharps Injury Prevention Features, a simulated clinical use (i.e. usability) testing was conducted using the Medline Safety Insulin and TB Syringes.
Biocompatibility Testing:
The biocompatibility evaluation for the Medline Safety Insulin and TB Syringes was conducted in accordance with ANSI/AAMI/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, indirect blood contact.
- Cytotoxicity in accordance with ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro Cytotoxicity
- Sensitization in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Test for Irritation and Skin Sensitization
- Irritation in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
- Acute Systemic Toxicity in accordance with ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- Hemolysis Assay in accordance with ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-Part 4:2017 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood
- Material-Mediated Pyrogenicity in accordance with USP Rabbit Pyrogen Test as recommended in ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- Subacute/ Subchronic Toxicity in accordance with ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- Complement Activation in accordance with ISO 10993-4: 2017 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood.
- Partial Thromboplastin Time in accordance with ISO 10993-4 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood.
- Platelet and Leukocyte Counts in accordance with ISO 10993-4:2017 Standard Biological Evaluation of Medical Devices, Part 4 – Selection of Tests for Interaction with Blood.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 18, 2023
Medline Industries, LP Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093
Re: K231907
Trade/Device Name: Medline Safety Insulin and TB Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: July 21, 2023 Received: July 21, 2023
Dear Kelsey Closen:
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).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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.
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-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,
erely, Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K231907
Device Name Medline Safety Insulin and TB Syringes
Indications for Use (Describe)
The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
| 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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3
Image /page/3/Picture/0 description: The image is the logo for Medline. The logo is set on a blue background. The word "MEDLINE" is in white, bold, sans-serif font. Above the word is a white starburst-like shape with four points.
ledline Industries. L Three Lakes Drive Northfield, IL 60093
K231907- 510(k) SUMMARY
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Contact Person
Contact Person: Kelsey Closen, Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen@medline.com
Summary Preparation Date October 19th 2023
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline Safety Insulin and TB Syringes Common Name: Tuberculin and Insulin Safety Syringes Classification Name: Syringe, Antistick and Syringe, Piston Product Code: MEG and FMF Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 880.5860
Predicate Device
Predicate Device: K061492, Kendall Monoject® Magellan Insulin and Tuberculin Safety Syringe
Device Description
The Medline Safety Insulin Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for delivery of U-100 Insulin. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver insulin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense insulin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending
4
Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. A white, stylized star shape is in the center, with the word "MEDLINE" in white, bold letters positioned horizontally across the star. The star shape has four points, with the top and bottom points being more elongated than the side points.
Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093
the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The Medline Safety Insulin Syringe barrel contains major and minor graduated ink markings and will be available in a 1 ml (100 units), and 0.5 ml (50 units) syringe volumes with three different needle gauge sizes.
The Medline TB Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for Tuberculin use. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver tuberculin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense tuberculin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The syringe barrel contains graduated markings, with major graduation markings every 0.05mL and minor graduation markings every 0.01mL. The Medline TB Syringe will be available in a 1 mL syringe volume with three different needle sizes.
Indications for Use
The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
| TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES | |||
|---|---|---|---|
| Device | |||
| Characteristic | Proposed Device | Predicate Device | Comparison |
| Analysis | |||
| Medline Safety Insulin and TB | |||
| Syringes | |||
| K231907 | Kendall Monoject Magellan and | ||
| Tuberculin Insulin Safety Syringe | |||
| K061492 | |||
| Product Code | MEG and FMF | FMF | Similar- |
| See comment #1 | |||
| Regulation Number | 21CFR 880.5860 | 21CFR 880.5860 | Same |
| Intended Use | Insulin Syringe: | ||
| The device is intended for the delivery | |||
| of U-100 insulin. The needle stick | |||
| prevention feature of the device, once | |||
| activated, guards against accidental | |||
| needle-sticks. | Insulin Syringe: | ||
| The device is intended for the delivery | |||
| of U-100 insulin. The needle stick | |||
| prevention feature of the device, once | |||
| activated, guards against accidental | |||
| needle-sticks. | Same | ||
| TB Syringe: | |||
| The device is intended for the delivery | |||
| of Tuberculin. The needle stick | |||
| prevention feature of the device, once | |||
| activated, guards against accidental | |||
| needle-sticks. | TB Syringe: | ||
| The device is intended for the delivery | |||
| of Tuberculin. The needle stick | |||
| prevention feature of the device, once | |||
| activated, guards against accidental | |||
| needle-sticks. | |||
| Design Features | -Manually operated safety feature to | ||
| prevent accidental needle sticks. | |||
| -Graduation markings | -Manually operated safety feature to | ||
| prevent accidental needle sticks. | |||
| -Graduation markings | Same | ||
| Mechanism of | |||
| Action | Insulin Syringe: | ||
| Mechanical delivery of U-100 insulin. | |||
| Needle-stick prevention feature is | |||
| mannually activated by the user by a | |||
| finger-tip or thumb operation. |
TB Syringe:
Mechanical delivery of tuberculin.
Needle-stick prevention feature is
manually activated by the user by a
finger-tip or thumb operation | Insulin Syringe:
Mechanical delivery of U-100 insulin.
Needle-stick prevention feature is
mannually activated by the user by a
finger-tip or thumb operation.
TB Syringe:
Mechanical delivery of tuberculin.
Needle-stick prevention feature is
manually activated by the user by a
finger-tip or thumb operation | Same |
| Components | Sterile Syringe
Single lumen needle
Safety sheild/feature | Sterile Syringe
Single lumen needle
Safety sheild/feature | Same |
| Prescription vs.
OTC | Prescription Use Only | Prescription Use Only | Same |
| Sterile vs. Non-
Sterile | Sterile | Sterile | Same |
| Sterilization Method | EO | EO | Same |
| Shelf life | 5 years | 5 years | Same |
| Single Use vs.
Reusable | Single Use | Single Use | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Size Configurations | Insulin Syringes:
1ml Syringe w/ Needle, 29G x 0.5in
1ml Syringe w/ Needle, 30G x 5/16in
1ml Syringe w/ Needle, 31G x 5/16in
1ml Syringe w/ Needle, 31G x 6mm
0.5ml Syringe w/ Needle, 29G x 0.5in
0.5ml Syringe w/ Needle, 30G x 5/16in
0.5ml Syringe w/ Needle, 31G x 5/16in
0.5ml Syringe w/ Needle, 31G x 6mm
TB Syringes: | Insulin Syringes:
1ml Syringe w/ Needle, 29G x 0.5in
1ml Syringe w/ Needle, 30G x 5/16in
0.5ml Syringe w/ Needle, 29G x 0.5in
0.5ml Syringe w/ Needle, 30G x 5/16in
0.3ml Syringe w/ Needle, 29G x 0.5in
0.3 ml Syringe w/ Needle, 30G x 5/16in
TB Syringes:
1 mL syringe w/ needle 25Gx5/8"
(0.508mm x 1.6cm) | Different –
See comment # 2
Reference
agency cleared
Iml syringes
with needle in
31G x6mm and
0.5ml syringe
with needle,
31G x6mm
(K220061) |
| | 1 mL Tuberculin Safety Syringe with
Needle, 25Gx5/8" (0.508 x 1.6 cm)
1 mL Tuberculin Safety Syringe with
Needle, 27Gx1/2" (0.356 mm x 1.3 cm)
1 mL Tuberculin Safety Syringe with
Needle, 28 G x 1/2" (0.356 mm x 1.3
cm | 1 mL syringe w/ needle, 28 Gx1/2"
(0.356mm x 1.3cm) | |
| Lubricant | Silicone | Silicone | Same |
| Needle Cap Color | Insulin: Orange
TB: Red, Grey and Brown | Insulin: Orange
TB: Orange, Red, Brown and Grey | Similar - see
comment #3 |
| Device Materials
(barrel and shield) | Polypropylene and Polyethylene | Polypropylene and Polyethylene | Same |
Summary of Technological Characteristics
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Image /page/5/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is oriented vertically, with its points extending upwards and downwards. A small portion of a gray rectangle is visible in the upper right corner of the image.
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol behind the text. The background is a solid dark blue color. The logo is simple and clean, with a professional look.
ledline Industries. LF Three Lakes Drive Northfield. IL 60093
Discussions of differences in technological characteristics
- . Comment #1 Medline also has MEG as a product code since the proposed devices make an anti-stick claim. Both of these product codes are defined by the same FDA requlation number (21 CFR 880.5860), and this difference does not impact Medline's ability to claim substantial equivalence.
- Comment # 2- Reference device cleared TB syringe 1mL with needle, 27Gx ½", Insulin syringe 1mL with needle 31G x 5/16″ and 0.5ml, 31Gx5/16" (K153537). Reference device cleared 1mL syringes with needle in 31Gx 6mm (K220061). The addition of 27Gx1/2", Insulin syringe 1mL with needle 31G x 5/16 including the 1ml with needle in 31Gx6mm does not raise different questions of safety and effectiveness than the predicate device.
- . Comment #3-The TB syringe cap colors are different among the proposed device and predicate device. Biocompatibility on the caps was conducted and supports that this difference does not impact the safety and effectiveness of the device to claim substantially equivalent to the predicate.
Shelf Life and Sterilization
The proposed Medline Safety Insulin and TB Syringe is terminally sterilized by Ethylene Oxide (EO). The sterilization validation for the proposed device has been conducted in accordance with ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices, to ensure a Sterility Assurance Level (SAL) of 1 x 10%. The proposed device has also been evaluated for EO and Ethylene Chlorohydrin (ECH) residuals in accordance with ISO 10993-7:2008(R)2012, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.
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Image /page/7/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized white cross symbol superimposed over the text. The background is a solid dark blue color, providing a strong contrast to the white text and cross.
ledline Industries. Three Lakes Drive Northfield II 60093
Additionally, in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify a five-year shelf life of the subject device and ensure that its functionality and sterility are successfully maintained throughout the duration of this shelf life. For additional information on the sterilization and shelf life of the proposed device, please refer to Section 14 of this submission. Test articles also underwent transportation-testing method, ISTA-3A:2008 and underwent a drop, vibration with top load, vibration without top load and a second drop test. After distribution stimulation, the test articles were tested to ASTM F1929:2015. Resistance to Dye Penetration.
Summary of Non-Clinical Performance Testing
Non-clinical verification of the Medline Safety Insulin and TB Syringes has been conducted to evaluate its 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:
Chemical Safety Testing
- Particulate Matter Testing in accordance with USP Particulate Matter in Injections ●
- Phthalate Testing .
- Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP ● Bacterial Endotoxin Testing
Functional Performance Testing
- . Visual Appearance Testing in accordance with ASTM F1886:2016 Standard Test Method For Determining Integrity Of Seals For Flexible Packaging By Visual Inspection
- Package Integrity Testing in accordance with ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- Seal Strength Testing in accordance with ASTM F88-21 Test Method for Seal Strength of Flexible ● Barrier Materials
- ISO 8537:2016 Sterile Single-Use Syringes, With or Without Needles, for Insulin ●
- ISO 23908:2011 Sharps Injury Protection Reguirements and Test Methods Sharps Protection ● Features for Single Use Hypodermic Needles, Introducers for Catheters and Needles Uses for Blood Sampling
- ISO 7864:2016 Sterile Hypodermic Needles for Single Use Requirements and Test Methods ●
- ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacturing of Medical Devices -● Requirements and Test Methods
- . ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use
Usability Testing
8
Image /page/8/Picture/0 description: The image shows the Medline logo, which features the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst or cross shape. The background is a solid, dark blue color. A small portion of a gray bar is visible on the right side of the image, partially obscuring the blue background.
ledline Industries
In accordance with the FDA guidance document Medical Devices with Sharps Injury Prevention Features, a simulated clinical use (i.e. usability) testing was conducted using the Medline Safety Insulin and TB Syringes.
Biocompatibility Testing
The biocompatibility evaluation for the Medline Safety Insulin and TB Syringes was conducted in accordance with ANSI/AAMI/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, indirect blood contact. Final biocompatibility test protocols and reports are available for the Agency's review in Appendix D.
- Cytotoxicity in accordance with ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro Cytotoxicity
- . Sensitization in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Test for Irritation and Skin Sensitization
- Irritation in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
- . Acute Systemic Toxicity in accordance with ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- . Hemolysis Assay in accordance with ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-Part 4:2017 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood
- Material-Mediated Pyrogenicity in accordance with USP Rabbit Pyrogen Test as ● recommended in ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- Subacute/ Subchronic Toxicity in accordance with ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
- Complement Activation in accordance with ISO 10993-4: 2017 Biological Evaluation of Medical . Devices-Part 4: Selection of Tests for Interactions with Blood.
- Partial Thromboplastin Time in accordance with ISO 10993-4 Biological Evaluation of Medical . Devices-Part 4: Selection of Tests for Interactions with Blood.
- Platelet and Leukocyte Counts in accordance with ISO 10993-4:2017 Standard Biological ● Evaluation of Medical Devices, Part 4 – Selection of Tests for Interaction with Blood.
Summary of Clinical Testing
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Not applicable.
Conclusion
The difference between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Medline Safety Insulin and TB Syringes are substantially equivalent to the Kendall Monoject Magellan Insulin and Tuberculin Safety Syringe with respect to the indications for use, target populations, treatment method, and technological characteristics.