K Number
K243332
Device Name
Promisemed Safety Huber Needles
Date Cleared
2025-03-14

(141 days)

Product Code
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.
Device Description
Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.
More Information

No reference devices were used in this submission.

No
The device description and performance studies focus on mechanical safety features and standard infusion set components. There is no mention of AI or ML in the text, and the performance metrics are based on physical properties and safety mechanism function, not algorithmic performance.

Yes
The device is used to access vascular ports and is designed for the infusion of substances, including contrast media for CT imaging, which are therapeutic or diagnostic procedures. Its intended use involves directly interacting with the patient's circulatory system for medical purposes.

No

Explanation: The device is an infusion set designed to access vascular ports for drug delivery or power injection of contrast media, not for diagnosing conditions. Its purpose is to facilitate the administration of substances, not to provide diagnostic information.

No

The device description explicitly details physical components such as a needle, tubing, injection site, clamp, and Luer lock adapter, and describes a mechanical safety mechanism. There is no mention of software as a component or function of the device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states the device is a "standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism." Its primary function is to access surgically implanted vascular ports for infusion or injection.
  • Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or perform any diagnostic tests on bodily fluids or tissues. Its purpose is purely for delivering substances into the body or potentially withdrawing fluids, but not for analyzing those fluids for diagnostic purposes.

Therefore, the device's intended use and description align with a medical device used for infusion/injection, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Product codes

PTI

Device Description

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention which reduces the risk of accidental needlestick injuries by sheathing the needle.

The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.

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

adult use only.

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)

Nonclinical tests were performed:

  • Name and labeling: Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 7864.
  • Needle length (type D): The needle's dimensions, including outer diameter and length, were measured, and found to comply with drawing requirements.
  • Performance test (type E): Full performance was tested, including appearance, dimension, safety mechanism, etc. and found to comply with ISO 7864, ISO 9626, ASTM F3212-16 and ISO 23908.

All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.

No clinical test is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K230715

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

March 14, 2025

Image /page/0/Picture/1 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 in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City, 311121, China

Re: K243332

Trade/Device Name: Promisemed Safety Huber Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: December 23, 2024 Received: February 12, 2025

Dear Zearou Yang:

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 QS 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.

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 Rue"). 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-device-advicecomprehensive-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-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).

2

Sincerely,

Rong Guo --> Digitally signed

Rong Guo --> by Rong Guo -S for

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

3

Indications for Use

Submission Number (if known)

K243332

Device Name

Promisemed Safety Huber Needles

Indications for Use (Describe)

The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaqing.

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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4

Image /page/4/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green and the word "med" is in blue. There is a blue and green molecule-like graphic above the word "Promise". There is a registered trademark symbol to the right of the word "med".

Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hanazhou City 311121 Zheiiana P R China

510(k) Summary

Date prepared: 2025-03-14

1. Manufacturer[21 CFR 807.92 (a) (1)]
NamePromisemed Hangzhou Meditech Co., Ltd.
AddressNo. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Contact PersonZearou Yang
Phone+86 571 88772985
Fax+86 571 88772985
Emailzearou.yang@promisemed.ca
2. Device [21 CFR 807.92 (a) (2)]
NamePromisemed Safety Huber Needles
Common NameSafety Huber Needles
Classification NameNeedle, Hypodermic, Single Lumen
Regulation Number880.5570
ClassClass II
Product CodePTI
3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)]
Predicate NameSafety Huber Needles
510(k) NumberK230715
Product CodePTI
Reference DevicesNo reference devices were used in this submission.
4. Device Description [21 CFR 807.92 (a) (4)]

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention which reduces the risk of accidental needlestick injuries by sheathing the needle.

The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.

  1. Indication for use [21 CFR 807.92 (a) (5)]

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Image /page/5/Picture/0 description: The image shows the logo for Promisemed. The word "Promise" is in blue, except for the "P" which is in green. To the left of the "r" is a green circle connected to a blue circle. To the right of the word "Promisemed" is a circled R, indicating that the logo is registered.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hanazhou City 311121 Zheijana P R China

The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Indications for Use Comparison [21 CFR 807.92 (a) (5)] 6.

No difference.

7. Comparison of Technological Characteristic [21 CFR 807.92 (a) (6)]

The subject device has the same intended use and technological characteristics as the predicate device. The similarities above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness or safety of the subject device when compared to the predicate device. The subject device is substantially equivalent to the identified predicate device.

At a high level, the subject and predicate devices are based on the following same technological elements:

| Item of
description | Cleared device
(K230715) | Modified device | Comments on
Similarities/
Differences | Safety/
Effectiveness
Statement | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Safety Huber Needles | No change | N/A | No new concerns.
The common
name remains
unchanged,
ensuring
consistency with
the intended use. | |
| Classification
name | Needle, Hypodermic, Single Lumen
(21 CFR 880.5570) | No change | N/A | No new concerns.
The classification
name remains
consistent. | |
| Device class | Class II | No change | N/A | No new concerns.
The device
remains in Class II,
indicating no
change in risk
level. | |
| Product Code | PTI | No change | N/A | No new concerns.
The product code
remains the same,
reflecting no
change in device
functionality. | |
| General
description | Safety Huber Needle is a standard
non-coring intravascular infusion set
with a non-coring Huber type right
angle needle and a manually
activated needle-stick prevention
safety mechanism which reduces the
risk of accidental needlestick injuries
by sheathing the needle.
The device includes an integrated
extension set consisting of a Huber
needle and safety mechanism (Type B
and Type C), needle infusion tubing
(pressure resistance or non-pressure
resistance), Y-injection site, clamp
and female Luer lock adapter. The
pressure resistance tubing can be
used for power injection up to 330
psi. The device will be retained on | Safety Huber Needle is a standard
non-coring intravascular infusion
set with a non-coring Huber type
right angle needle and a manually
activated needle-stick prevention
safety mechanism which reduces
the risk of accidental needlestick
injuries by sheathing the needle.
The device includes an integrated
extension set consisting of a Huber
needle and safety mechanism
(Type B, Type D and Type E), needle
infusion tubing (pressure resistance
or non-pressure resistance), Y-
injection site, clamp and female
Luer lock adapter. The pressure
resistance tubing can be used for
power injection up to 330 psi. The | Name of Type
C is changed to
Type D.
Type E was
added. | No new concerns.
The change to
type name and a
broader type do
not introduce
new risks as the
fundamental
technology and
operation remain
the same. | |
| | patient for 24h to 7 days. | device will be retained on patient
for 24h to 7 days. | | | |
| Principle of
operation | Type B and Type C:
The Safety Huber Needle is for
insertion into the septum of a
subcutaneously implanted port and
for the infusion of fluids into the port.
It is designed with flexible wings
which allow the user to securely hold
the device for insertion and removal
of the needle. The protective base
and protective shield are made of
clear plastic that allow the user to
visualize placement of the needle. A
foam pad is present on the patient-
contacting side of the protective
base.
The device include a safety design
allowing the safety shield covers the
needle tip after usage. | Type B and Type D:
No change | Name of Type
C is changed to
Type D. | No new concerns.
The principles of
operation remain
unchanged,
ensuring
consistent
performance. | |
| | / | Type E:
Same as Type D | Type E was
added. | | |
| Indication of use | The needle is used to access surgically
implanted vascular ports.
Safety Huber Needles is a standard
non coring intravascular infusion set
with a non-coring Huber type right
angle needle and a manually
activated needle stick prevention
safety mechanism which reduces the
risk of accidental needlestick injuries
by sheathing the needle. This device
is for adult use only.
In addition, when used with ports
that are indicated for power injection
of contrast media into the central
venous system, the high pressure
resistant model is indicated for high-
pressure injection of contrast media
for CT imaging. | No change. | N/A | No new concerns.
The change to
type name and a
broader type do
not introduce
new risks as the
fundamental
technology and
operation remain
the same. | |
| Type | Type B, Type C | Type B, Type D and Type E | Name of Type
C is changed to
Type D.
Type E was
added. | No new concerns.
The change to
type name and a
broader type do
not introduce
new risks as the
fundamental
technology and
operation remain
the same. | |
| Needle size | 19G, 20G, 22G | No change | N/A | No new concerns.
The needle size
remains
unchanged. | |
| Needle length | Type B:19mm, 25mm, 38mm | No change | N/A | No new concerns.
The needle length
remains
unchanged. | |
| | Type C:19mm, 25mm, 38mm | Type D: 13mm, 15mm, 19mm,
25mm, 32mm, 38mm | Name of Type
C is changed to
Type D.
New needle
length sizes
were added for
Type D. | No new concerns.
The addition of
new lengths do
not introduce
new risks as the
fundamental
technology and | |
| | / | Type E: 13mm, 15mm,
19mm,
25mm, 32mm, 38mm | Type E was
added. | operation remain
the same. | |
| Needle bevel
design | Non-coring angled needle | No change | N/A | No new concerns.
The addition of
new lengths and
new type do not | |
| | | | | | |
| Color | Needle gauge

19G

20G

22G | Color

Cream

Yellow

Black | Type B, Type D and Type E: No change; | Color designation system is remained no change.
The color for Type E is indicated on the clamp. | introduce new risks as the fundamental technology and operation remain the same.

No new concerns. The addition of new lengths and new type do not introduce new color system requirement as met with ISO 6009. |
| Schematic diagram
(safety mechanism) | Image: Type B with wing hub, protective shield, and Huber Needle | | No change | Name of Type C is changed to Type D.
Type E was added.
The difference of Type E and Type D is only the shape of hub which Type E is without wing. | No new concerns. The addition of new type do not introduce new risks as the fundamental technology and operation remain the same. |
| | Image: Type C with wing hub, protective shield, and Huber Needle | | No change | | |
| | Image: Type E with Needle hub, protective shield, and Huber needle | | / | | |
| Material | Type B, Type C | | Type B, Type D: No change Type E added. | Name of Type C is changed to Type D.
Type E is without wing and other component material is same with type D. | No new concerns. Type E is without wing and other material is same with type D and does not affect safety. |
| Performance requirements | Remain no change | | No change | N/A | No new concerns. Performance requirements remained unchanged, ensuring consistent functionality. |
| Labeling | Remain no change | | Type B, Type D and Type E | Name of Type C is changed to Type D. Type E was added. | No new concerns. Labeling updates meet current standards and enhance the device's safety and usability. |

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Image /page/6/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. There is a green and blue atom-like graphic above the "o" in "Promise". There is a registered trademark symbol to the right of the word "Promisemed".

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

7

Image /page/7/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. The "Pro" part of the word is green, while the rest of the word is blue. There is a green and blue graphic above the word, and a registered trademark symbol to the right of the word.

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

8

Image /page/8/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green, while the word "med" is in blue. There is a green and blue atom-like structure above the "P" in "Promise". There is a registered trademark symbol to the right of the word "Promisemed".

No. 1388 Canaxing Street. Canagian Community. Yuhang District.

8. Nonclinical test [21 CFR 807.92 (b) (1)]

To support substantial equivalence to the predicate device, Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.

Verification and Validation Activities - Design Changes:

  • � Name and labeling: Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 7864.
  • ◆ Needle length (type D): The needle's dimensions, including outer diameter and length, were measured, and found to comply with drawing requirements.
  • � Performance test (type E): Full performance was tested, including appearance, dimension, safety mechanism, etc. and found to comply with ISO 7864, ISO 9626, ASTM F3212-16 and ISO 23908.

All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.

9. Clinical test [21 CFR 807.92 (b) (2)]

No clinical test is included in this submission.

10. Conclusion [21 CFR 807.92 (b) (3)]

Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.