(450 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard biocompatibility testing, with no mention of AI or ML.
No.
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is an insulin syringe, which is used for the delivery of insulin (a drug), not for therapy itself.
No
Explanation: The device is an insulin syringe intended for the injection of U-100 insulin, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical syringe with a needle and a safety mechanism, not a software application.
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 "injection of U-100 insulin into the body". This is a therapeutic action, delivering a substance into the body for treatment.
- Device Description: The description focuses on the physical mechanism of the syringe for injection and safety features related to preventing needle sticks.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to test samples (like blood, urine, tissue) outside of the body to gain information about a person's health status. This device is used to administer a substance directly into the body.
N/A
Intended Use / Indications for Use
The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The TK Insulin Syringe is a sterile, single-use, disposable, insulin syringe intended for injection of U-100 insulin into the body.
Product codes
MEG, FMF
Device Description
The TK Insulin Syringe with/without Safety Retractable Device are similar devices except one has a safety feature and the other is a standard insulin syringe.
The TK Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharp's container.
The subject devices are sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The TK Insulin Syringe with/without Safety Retractable Device will be available in numerous sizes and combinations in the following table.
Ref Number: TKIS001, Model Number: TKIS, Description: Insulin Syringe, Size: 0.3cc/ml Needle 27G × 1/2", 0.3cc/ml Needle 28G × 1/2", 0.3cc/ml Needle 29G × 1/2", 0.3cc/ml Needle 30G × 1/2", 0.3cc/ml Needle 31G × 3/8"
Ref Number: TKIS002, Model Number: TKIS, Description: Insulin Syringe, Size: 0.5cc/ml Needle 27G × 1/2", 0.5cc/ml Needle 28G × 1/2", 0.5cc/ml Needle 29G × 1/2", 0.5cc/ml Needle 30G × 1/2", 0.5cc/ml Needle 31G ×3/8"
Ref Number: TKIS003, Model Number: TKIS, Description: Insulin Syringe, Size: 1cc/ml Needle 27G × 1/2", 1cc/ml Needle 28G × 1/2", 1cc/ml Needle 29G × 1/2", 1cc/ml Needle 30G × 1/2", 1cc/ml Needle 31G × 3/8"
Ref Number: TKSIS001, Model Number: TKSIS, Description: Insulin Syringe with Safety Retractable Device, Size: 0.5cc/ml Needle 27G × 1/2", 0.5cc/ml Needle 28G × 1/2", 0.5cc/ml Needle 29G × 1/2", 0.5cc/ml Needle 30G × 1/2", 0.5cc/ml Needle 31G × 3/8"
Ref Number: TKSIS002, Model Number: TKSIS, Description: Insulin Syringe with Safety Retractable Device, Size: 1cc/ml Needle 27G × 1/2", 1cc/ml Needle 28G × 1/2", 1cc/ml Needle 29G × 1/2", 1cc/ml Needle 30G × 1/2", 1cc/ml Needle 31G × 3/8"
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 Tests were performed on the subject device per the following standards to evaluate its performance:
- ISO 8537: 2016 Third edition, Sterile single-use syringes, with or without needle, for insulin.
- ISO 7864:2016 Fourth edition, Sterile hypodermic needles for single use-Requirements and test method.
For the TK Insulin Syringe with Safety Retractable Device Only:
- ISO 9626:2016 Second edition 2016-08-01 Stainless steel needle tubing for manufacture of medical device-Requirements and test method.
- ISO 23908:2011 First edition 2011-06-11 Sharps Injury Protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
- Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features.
Biocompatibility tests were performed as the device is classified as prolonged, external communicating device, indirect blood contact with the following endpoints:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous reactivity
- Acute systemic toxicity
- Material mediated pyrogenicity
- Subacute/Subchronic toxicity
- Indirect hemolysis
- USP 788
- ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- USP : Particulate Matter for injection
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
September 11, 2020
Anhui Tiankang Medical Technology Co.,Ltd. Bai Baodong RA Manager No.228 Weiyi Road, Economic Development Zone Tianchang, 239300 Cn
Re: K191639
Trade/Device Name: TK Insulin Syringe with/without Safety Retractable Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF Dated: August 13, 2020 Received: August 13, 2020
Dear Bai Baodong:
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 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
1
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 mediation-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,
For CAPT Alan 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
2
Indications for Use
510(k) Number (if known) K191639
Device Name
TK Insulin Syringe with/without Safety Retractable Device
Indications for Use (Describe)
The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The TK Insulin Syringe is a sterile, single-use, disposable, insulin syringe intended for injection of U-100 insulin into the body.
| 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
510(K) Summary: K191639
Date prepared: 09.11.2020
1. Submitter Name and Address:
| Owner Name: | Anhui Tiankang Medical Technology Co.,Ltd. |
|---|---|
| Address: | No.228 Weiyi Road, Development Zone, |
| Tianchang City, Anhui,China | |
| Contactor Name: | Bai Baodong |
| TEL: | +86-550-7309187 |
| E-mail: | zy@tkmedical.com |
Manufacturer
| Name: | Anhui Tiankang Medical Technology Co.,Ltd |
|---|---|
| Address: | No.228 Weiyi Road, Economic Development |
| Tianchang City, Anhui,China |
US Agent:
| US Agent: | James H . Liao |
|---|---|
| Address: | 6775 Verde Ridge Rd Rancho Palos Verdes, CA 90275 |
| TEL: | 310 3758169 Ext |
| Email: | James@Sino2us.Com |
2.Submission Devices :
Product Name: TK Insulin Syringe with/without Safety Retractable Device Classification Name: Syringe, Antistick Piston Syringe Classification : II. Product code: MEG and FMF Submission Type: 510(K) Traditional Regulation Number: 21 CFR 880.5860
3.Predicate Device :
Product Name: U&U Insulin Syringe with/without Safety Retractable Device Classification name: Syringe, Antistick Piston Syringe Classification: II Product Code: MEG and FMF Regulation No. 21 CFR 880.5860 Review Panel :80
4
4. Indication for Use
The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The TK Insulin Syringe is a sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
5. Device Description:
The TK Insulin Syringe with/without Safety Retractable Device are similar devices except one has a safety feature and the other is a standard insulin syringe.
The TK Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharp's container.
The subject devices are sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The TK Insulin Syringe with/without Safety Retractable Device will be available in numerous sizes and combinations in the following table.
| Ref Number | Model Number | Description | Size |
|---|---|---|---|
| TKIS001 | TKIS | Insulin Syringe | 0.3cc/ml Needle 27G × 1/2" |
| 0.3cc/ml Needle 28G × 1/2" | |||
| 0.3cc/ml Needle 29G × 1/2" | |||
| 0.3cc/ml Needle 30G × 1/2" | |||
| 0.3cc/ml Needle 31G × 3/8" | |||
| TKIS002 | TKIS | Insulin Syringe | 0.5cc/ml Needle 27G × 1/2" |
| 0.5cc/ml Needle 28G × 1/2" | |||
| 0.5cc/ml Needle 29G × 1/2" | |||
| 0.5cc/ml Needle 30G × 1/2" |
5
| 0.5cc/ml Needle 31G ×3/8" | |||
|---|---|---|---|
| TKIS003 | TKIS | Insulin Syringe | 1cc/ml Needle 27G × 1/2" |
| 1cc/ml Needle 28G × 1/2" | |||
| 1cc/ml Needle 29G × 1/2" | |||
| 1cc/ml Needle 30G × 1/2" | |||
| 1cc/ml Needle 31G × 3/8" | |||
| TKSIS001 | TKSIS | Insulin Syringe with Safety | |
| Retractable Device | 0.5cc/ml Needle 27G × 1/2" | ||
| 0.5cc/ml Needle 28G × 1/2" | |||
| 0.5cc/ml Needle 29G × 1/2" | |||
| 0.5cc/ml Needle 30G × 1/2" | |||
| 0.5cc/ml Needle 31G × 3/8" | |||
| TKSIS002 | TKSIS | Insulin Syringe with Safety | |
| Retractable Device | 1cc/ml Needle 27G × 1/2" | ||
| 1cc/ml Needle 28G × 1/2" | |||
| 1cc/ml Needle 29G × 1/2" | |||
| 1cc/ml Needle 30G × 1/2" | |||
| 1cc/ml Needle 31G × 3/8" |
6. Comparison of technological characteristics with the predicate:
Through comparisons between the submitted devices with the predicate devices as follows Tables. We believe the applicant devices are substantially equivalent with the predicate devices.
The main components of a TK insulin syringe with a safety retractable device are manufactured to the same or similar specifications as the said assertion device. The intended use, basic design, function, and materials of the predicate device are identical to or similar to the predicate device. The difference between the subject device and the predicate does not affect the safety and effectiveness of the subject device because the evaluation is conducted using industry consensus standards and based on the performance requirements of the device. Therefore, different technical features do not introduce new safety and effectiveness issues and are essentially equivalent to predicate devices.
6
Comparison Table
| Element of
| Comparison | Submission Device | Predicate Device K152808 | Comment |
|---|---|---|---|
| Intended Use | The TK Insulin Syringe with | ||
| Safety Retractable Device is a | |||
| sterile, single-use, disposable | |||
| and non-reusable, manual | |||
| retractable safety insulin | |||
| syringe intended for injection | |||
| of U-100 insulin into the body, | |||
| while reducing the risk of | |||
| sharps injuries and the | |||
| potential for insulin syringe | |||
| reuse. |
The TK Insulin Syringe is a
sterile, single-use, disposable
and non-reusable, insulin
syringe intended for injection
of U-100 insulin into the body. | The U&U Insulin Syringe with
Safety Retractable Device is a
sterile, single-use, disposable and
non-reusable, manual
retractable safety insulin syringe
intended for injection of U-100
insulin into the body, while
reducing the risk of sharps injuries
and the potential for insulin
syringe reuse.
The U&U Insulin Syringe is a
sterile, single-use, disposable and
non-reusable, insulin syringe
intended for injection of U-100
insulin into the body. | Same |
| Principle of Operation | Normal | Normal | Same |
| Syringe Capacity | TK Insulin Syringe:
0.3cc/ml Needle 27G × 1/2"
0.3cc/ml Needle 28G × 1/2"
0.3cc/ml Needle 29G × 1/2"
0.3cc/ml Needle 30G × 1/2"
0.3cc/ml Needle 31G × 3/8"
0.5cc/ml Needle 27G × 1/2"
0.5cc/ml Needle 28G × 1/2"
0.5cc/ml Needle 29G × 1/2"
0.5cc/ml Needle 30G × 1/2" | U&U Insulin Syringe
0.3cc/ml Needle 27G to 31G
0.5cc/ml Needle 27G to 31G
1cc/ml Needle 27G to 31G
U&U Insulin Syringe with Safety
Retractable Device:
1cc/ml only Needle 27G to 31G | Different
Because there
are many
customers in
our market who
need 0.5cc/ml,
which indicates
that customers
have demand
for this
specification,
we have added
0.5cc/ml in the
syringe |
| | 0.5cc/ml Needle 31G × 3/8" | | capacity.
Adding 0.5mL
does not affect
the safety and
effectiveness of
the subject
device and is
verified by
non-clinical
testing listed in
Section 7. |
| | 1cc/ml Needle 27G × 1/2" | | |
| | 1cc/ml Needle 28G × 1/2" | | |
| | 1cc/ml Needle 29G × 1/2" | | |
| | 1cc/ml Needle 30G × 1/2" | | |
| | 1cc/ml Needle 31G × 3/8" | | |
| | TK Insulin Syringe with
Safety Retractable Device: | | |
| | 0.5cc/ml Needle 27G × 1/2" | | |
| | 0.5cc/ml Needle 28G × 1/2" | | |
| | 0.5cc/ml Needle 29G × 1/2" | | |
| | 0.5cc/ml Needle 30G × 1/2" | | |
| | 0.5cc/ml Needle 31G × 3/8" | | |
| | 1cc/ml Needle 27G × 1/2" | | |
| | 1cc/ml Needle 28G × 1/2" | | |
| | 1cc/ml Needle 29G × 1/2" | | |
| | 1cc/ml Needle 30G × 1/2" | | |
| | 1cc/ml Needle 31G × 3/8" | | |
| Nozzle Type | N.A | N.A | Same |
| Lubricant for Barrel | Silicone Oil | Silicone Oil | Same |
| Barrel Transparency | Transparent and Clear | Transparent and Clear | Same |
| Gradations Legibility | Legible | Legible | Same |
| Materials | | | |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | |
| | | | Same |
| Piston | Rubber | Rubber | |
| Lubricant for Barrel | HC-SS36 | | |
| Needle Hub | PP | | |
| Needle | Stainless | | |
| Needle Sheath | PP | | |
| Needle Gauge and
Length | Various Sizes | Same | |
| Lubricant for Needle | Silicone Oil | Same | |
| TK Insulin Syringe
with Safety Retractable
Device: Sharps Injury
Prevention Features | Manual Retractable Conforms
to ISO 23908 | Same | |
| Performances | Conforms to ISO7864
ISO8537 | Same | |
| Biocompatibility | Conforms to ISO10993(Part 1: Evaluation and testing, Part 4: Selection of tests for interactions with blood, Part 5: Tests for in vitro cytotoxicity, Part 7: Ethylene oxide sterilization residuals, Part 10: Tests for irritation and delayed-type hypersensitivity, Part 11: Tests for systemic toxicity, Tests for Bacterial endotoxins, Tests for Pyrogenicity)
Conforms to USP :
Particulate Matter for injection | Conforms to ISO10993(Part 1: Evaluation and testing, Part 4: Selection of tests for interactions with blood, Part 5: Tests for in vitro cytotoxicity, Part 7: Ethylene oxide sterilization residuals, Part 10: Tests for irritation and delayed-type hypersensitivity, Part 11: Tests for systemic toxicity)
Conforms to USP :
Particulate Matter for injection | Same |
| Labeling | Meet the requirements of
21 CFR Part 801 | Same | |
7
8
7.Non-Clinical Tests performed on the subject device:
The proposed devices were tested per the following standards, to evaluate its performance.
[PMN-510(K) SUBMISSION]
9
- ISO 8537: 2016 Third edition, Sterile single-use syringes, with or without ● needle, for insulin.
- ISO 7864:2016 Fourth edition, Sterile hypodermic needles for single use-● Requirements and test method.
For the TK Insulin Syringe with Safety Retractable Device Only:
- ISO 9626:2016 Second edition 2016-08-01 Stainless steel needle tubing for manufacture of medical device-Requirements and test method.
- . ISO 23908:2011 First edition 2011-06-11 Sharps Injury Protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
- Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury . Prevention Features:
Biocompatibility
Conforms to ISO10993. The TK Insulin Syringe with/without Safety Retractable Device is classified as prolonged, external communicating device, indirect blood contact with the following endpoints:
- . Cytotoxicity
- . Sensitization
- Irritation or Intracutaneous reactivity ●
- . Acute systemic toxicity
- . Material mediated pyrogenicity
- Subacute/Subchronic toxicity
- Indirect hemolysis
- . USP 788
- . ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- · ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
10
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- USP : Particulate Matter for injection
8. Conclusions:
The TK Insulin Syringe with/without Safety Retractable Device is substantially equivalent to the U&U Insulin Syringe with Safety Retractable Device. The materials, performance, and operational features of both the subject device and the predicate devices are substantially equivalent.