(246 days)
No
The device description and performance studies focus on the mechanical and safety features of a hypodermic needle and syringe, with no mention of AI or ML capabilities.
No
The device is described as a needle and syringe for general purpose injection and fluid transfer, with a safety feature to prevent needle-stick injuries. Its intended use does not involve treating or diagnosing a disease or condition, but rather facilitating the administration or removal of substances.
No
Explanation: The device is described as a needle and syringe for general purpose injection of fluid, not for diagnosing medical conditions. Its function is to administer substances, not to detect or identify diseases.
No
The device description clearly outlines physical components (needle, safety device, syringe) and mentions manufacturing processes (sterilization), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin." This describes a device used for administering substances into or withdrawing substances from the body, which is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of a needle and syringe designed for injection, including safety features to prevent needlestick injuries. There is no mention of components or functions related to analyzing samples in vitro (outside the body).
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is clearly intended for direct interaction with the patient's body for the purpose of injection or aspiration, which falls under the category of medical devices used for treatment or procedures, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.
The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
FMI, FMF
Device Description
The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe.
The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL.
The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intramuscular, intravascular, or subcutaneous injection
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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)
Bench testing was performed on the subject device and the predicate device.
A simulated clinical study was performed according to FDA Guidance, Medical Devices with Sharps Injury Prevention Features. Five hundred (500) subject devices were evaluated across 10 trained professionals. There were no device failures, no user-related adverse events or safety device related adverse events.
Internal verification and validation testing confirms that the SafeTouch Needle with or without Syringe meets specifications equivalent in design and technological characteristics to the predicate device.
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
§ 880.5570 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2023
Nipro Medical Corporation Jessica Oswald-Mcleaod Director, Quality and Regulatory 3150 NW 107th Ave. Doral, Florida 33172
Re: K222852
Trade/Device Name: Nipro SafeTouch Needle; Nipro SafeTouch Needle with Syringe Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: April 25, 2023 Received: April 28, 2023
Dear Jessica Oswald-Mcleaod:
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.
1
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 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,
Image /page/1/Picture/5 description: The image shows a digital signature of Courtney Evans -S. The signature includes the date 2023.05.25 and the time 15:33:54 -04'00'. The signature is likely used to verify the authenticity and integrity of a digital document.
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) K222852
Device Name
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
Indications for Use (Describe)
The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.
The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Nipro. The logo consists of a blue abstract symbol on the left and the word "NIPRO" in blue block letters on the right. The abstract symbol appears to be two interlocking shapes, possibly representing two links in a chain.
K222852 510(K) Summary
Prepared on: May 23, 2023
1. Contact Details - 21 CFR 807.92(a)(1)
| Applicant Name: | Nipro Medical Corporation, North America division |
|---|---|
| Applicant Address: | 3150 NW 107th Ave. Doral FL 33172 USA |
| Establishment Registration: | 1056186 |
Contact Person:
| Contact Person: | Jessica Oswald-McLeod |
|---|---|
| Director, Quality and Regulatory | |
| Phone: | 1-305-432-6699 |
| JessicaO@nipromed.com |
2. Device Name - 21 CFR 807.92(a)(2)
| Trade Name: | Nipro SafeTouch Needle Nipro Syringe with SafeTouch Needle |
|---|---|
| Common Name: | Disposable Syringe with Safety Needle |
| Classification Name: | Piston syringe, Hypodermic single lumen needle |
| Regulation Number: | 880.5860, 880.5570 |
| Panel: | General Hospital (80) |
| Product Code: | FMF, FMI |
| Regulatory Class: | Class 2 |
3. Legally Marketed Predicate Device - 21 CFR 807.92(a)(3)
K162081: BD 1mL Luer-lok Hypodermic Syringe with BD Eclipse Hypodermic Needle
4. Device Description Summary - 21 CFR 807.92(a)(4)
The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe.
The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL.
4
Image /page/4/Picture/0 description: The image shows the logo for Nipro. The logo consists of a blue symbol that looks like two interlocking infinity symbols. To the right of the symbol is the word "NIPRO" in blue, block letters. The background is white.
4.1 Nipro Syringe with SafeTouch Needle Configurations
| Syringe Volume (mL) | Needle Gauge | Needle Length (inches) |
|---|---|---|
| 1 | 25 | 5/8 |
| 27 | 1/2 | |
| 30 | 1/2 | |
| 3 | 25 | 1/2 |
| 23 | 1 | |
| 22 | 1 | |
| 21 | ||
| 20 | ||
| 18 | ||
| 5 | 22 | |
| 21 | 1 | |
| 20 | 1-1/2 | |
| 10 | 22 | |
| 21 | ||
| 20 |
4.2 Nipro SafeTouch Needle Configurations
| Needle Gauge | Needle Length (inches) |
|---|---|
| 18 | |
| 19 | 1 |
| 20 | 1-1/2 |
| 21 | |
| 22 | 3/4 |
| 1 | |
| 1-1/2 | |
| 23 | 1 |
| 1-1/2 | |
| 25 | 5/8 |
| 1 | |
| 1-1/2 |
5
Image /page/5/Picture/0 description: The image shows the logo for Nipro. The logo consists of a blue abstract symbol on the left and the word "NIPRO" in blue on the right. The abstract symbol appears to be two interlocking shapes, possibly representing the letter "N". The word "NIPRO" is written in a bold, sans-serif font.
| Needle Gauge | Needle Length (inches) |
|---|---|
| 26 | 1/2 |
| 27 | 1/2 |
| 27 | 1 1/4 |
| 30 | 1/2 |
The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.
The Nipro Svringe with SafeTouch Needle is identical to the reference device. K944355 Nioro Disposable Syringes and Needles, in terms of manufacturing and sterilization methods and facilities and materials of construction. This submission is to add the safety shield to the hypodermic needle and market it independently as well as attached to a Nipro luer-lock syringe.
5. Intended Use/Indications for Use - 21 CFR 807.92(a)(5)
The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.
The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.
6. Technology Comparison - 807.92(a)(6)
The subject device is identical to the predicate device in operational mode, physical construction, and intended use. Both devices contain a mechanism that requires physical action by the clinician to cover the needlepoint after use protecting against accidental needlesticks. Once activated, the safety cannot be deactivated.
They are provided sterile with a 5-year shelf-life and are for single use only. They have patient contact and duration.
| Item for Comparison | Subject device:
K222852 SafeTouch
Needle / Syringe
with SafeTouch
Needle | Predicate device:
K162081 BD Luer-
Lok™ Hypodermic
Syringe with
BD Eclipse™
Hypodermic Needle | Conclusion | |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 1. Device Description | | | | |
| 1.1. Indications for
Use | The Nipro SafeTouch
Needle with syringe is
indicated for general
purpose injection and
aspiration of fluid to | The BD 1mL Luer-
Lok™ Hypodermic
Syringe with BD
Hypodermic Needle or
BD Eclipse™ | Similar - no new
issues of safety and
effectiveness | |
| Item for Comparison | Subject device:
K222852 SafeTouch
Needle / Syringe
with SafeTouch
Needle | Predicate device:
K162081 BD Luer-
Lok™ Hypodermic
Syringe with
BD Eclipse™
Hypodermic Needle | Conclusion | |
| | and from parts of the
body below the surface
of the skin. It includes
a needle shield to
prevent against
accidental needlestick
injuries. | Hypodermic Needle is
intended for use by
health care
professionals for
general purpose
injection and
aspiration of fluid from
vials, ampoules, and
parts of the body
below the surface of
the skin. The BD
Eclipse™ Hypodermic
Needle contains a
mechanism that covers
the needlepoint after
use. In the activated
position the needle
cover guards against
accidental needle
sticks during normal
handling and disposal
of the used needle/
syringe combination. | | |
| 1.2. Mechanism of
Action | Mechanical/Manual | Mechanical/Manual | Same | |
| 1.3. Technology
Overview | Graduated disposable
piston syringe provided
with a safety
hypodermic needle
consisting of a
Stainless-Steel cannula
with plastic hub and
needle shield. | Graduated disposable
piston syringe
provided with a safety
hypodermic needle
consisting of a
Stainless-Steel cannula
with plastic hub and
needle shield. | Same | |
| 1.4. Anatomical
Location | intramuscular,
intravascular, or
subcutaneous injection | intramuscular,
intravascular, or
subcutaneous injection | Same | |
| Item for Comparison | Subject device:
K222852 SafeTouch
Needle / Syringe
with SafeTouch
Needle | Predicate device:
K162081 BD Luer-
Lok™ Hypodermic
Syringe with
BD Eclipse™
Hypodermic Needle | Conclusion | |
| 2.1. Syringe barrel | Polypropylene | Styrene acrylic
copolymer | Similar - no new
issues of safety and
effectiveness | |
| 2.2. Lubricant | Silicone | Silicone | Same | |
| 2.3. Plunger | Polypropylene | Polypropylene | Same | |
| 2.4. Stopper | Polyisoprene Rubber | Polyisoprene Rubber | Same | |
| 2.5. Needle Cannula | Stainless Steel | Stainless Steel | Same | |
| 2.6. Needle Hub with
integrated safety
mechanism
(needle shield) | Polypropylene | Polypropylene | Same | |
| 3. Physical Characteristics | | | | |
| 3.1. Needle Gauge | 18 - 30 | 20 - 30 | Nipro provides a larger
gauge needle. Testing
results demonstrate no
new issues of safety
and effectiveness | |
| 3.2. Needle hub Color | The needle hub is
color-coded to the
appropriate gauge
needle per ISO 6009 | The needle hub is
color-coded to the
appropriate gauge
needle per ISO 6009 | Same | |
| 3.3. Needle Length | 1/2" - 1 1/2" | 1/2" - 1 | Nipro provides a longer
length needle. Testing
results demonstrate no
new issues of safety
and effectiveness | |
| 3.4. Syringe Volume | 1 - 10 mL | 1-10mL | Same | |
| 4. Sterility | | | | |
| 4.1. Method | EO | Gamma | Both methods are
recognized as Category
A. | |
| 4.2. Single-Use | yes | yes | Same | |
| 4.3. SAL | 10-6 | 10-6 | Same | |
| | Item for Comparison | Subject device:
K222852 SafeTouch
Needle / Syringe
with SafeTouch
Needle | Predicate device:
K162081 BD Luer-
Lok™ Hypodermic
Syringe with
BD Eclipse™
Hypodermic Needle | Conclusion |
| | 4.4. Shelf Life | 5 years | 5 years | Same |
| 5. | Biological Specifications | | | |
| 5.1. | Systemic
Injection | No abnormalities or
mice death | No abnormalities or
mice death | Within Criteria; Same |
| | 5.2. Intracutaneous
reaction test | No erythema, edema,
or necrosis | No erythema, edema,
or necrosis | Within Criteria; Same |
| | 5.3. Hemolysis test | Hemolytic index shall
not exceed 2% | Hemolytic index shall
not exceed 2% | Within Criteria; Same |
| | 5.4. Bacterial
Endotoxin | , USP ) e.
- Shelf-life testing (ASTM F1980-07) f.
- g. Packaging and Transportation tests (ASTM D4169-16)
- h. Dye Penetration packaging tests (ASTM F1929-15)
- Biocompatibility and Chemical Characterization (ISO 10993-1) i.
- Cytotoxicity: MEM Elution (ISO 10993-5) 트
- . Systemic Toxicity: Systemic Injection (ISO 10993-11)
- . Sensitization: Guinea Pig Maximization (ISO 10993-10)
- Irritation: Intracutaneous Reactivity (ISO 10993-23) "
- 트 Pyrogenicity:
9
Image /page/9/Picture/0 description: The image shows the logo for Nipro. The logo consists of a blue abstract symbol on the left and the word "NIPRO" in blue capital letters on the right. The abstract symbol appears to be two interlocking shapes, possibly representing two links in a chain.
- Bacterial Endotoxin (BET) (ANSI/AAMI ST72:2011/(R)2016, USP-NF M98910 01 01 -, USP-NF M98830 02 01 ,)
- Material mediated (USP-NF) -
- I Hemocompatibility: Hemolysis (indirect) and Direct contact (ISO 10993-4 and ASTM F756)
- . Sterilization Residuals: EO/ECH Residuals (ISO 10993-7)
- . Particulates Testing: Sizing and counting Particulates: Light Obscuration Method (USP )
A simulated clinical study was performed according to FDA Guidance, Medical Devices with Sharps Injury Prevention Features. Five hundred (500) subject devices were evaluated across 10 trained professionals. There were no device failures, no user-related adverse events or safety device related adverse events.
Internal verification and validation testing confirms that the SafeTouch Needle with or without Syringe meets specifications equivalent in design and technological characteristics to the predicate device.
8. Conclusion Statement
The SafeTouch Needle with or without Syringe complies with all applicable voluntary consensus for performance, biocompatibility, packaging, transportation. Through functional performance testing the subject devices have demonstrated substantial equivalence to the predicate device.