Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and standard testing, with no mention of AI/ML terms or data processing capabilities.

Therapeutic

No.
The device is used to access surgically implanted vascular ports for infusion and injection, and its primary function is access and safety, not direct therapeutic action on a disease or condition.

Diagnostic

No

Explanation: The Safety Huber Needle is an infusion set used to access vascular ports for infusion or injection of substances, including contrast media for CT imaging. It is not designed to diagnose specific conditions or diseases. Its function is to facilitate the delivery of substances rather than to collect data for diagnostic interpretation.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a needle, tubing, Y-injection site, clamp, and Luer lock adapter, and the performance studies focus on physical and biological testing of these components. There is no mention of software as part of the device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to access surgically implanted vascular ports for infusion and potentially power injection of contrast media. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic imaging purposes, not for examining specimens derived from the human body in vitro.
Device Description: The description details a needle, tubing, and safety mechanisms for delivering substances into the body. It does not mention any components or functions related to analyzing biological samples outside of the body.
Performance Studies: The performance studies listed focus on the physical properties of the device (strength, sterility, biocompatibility, flow rate, etc.) and its interaction with the body and fluids being infused. There are no studies related to the analysis of biological samples or diagnostic accuracy.

IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body, which is a different category of medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 needlestick 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 patient for 24h to 7 days.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

surgically implanted vascular ports

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)

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

ISO 8536-4 :2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ISO 23908:2011, Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
ANSI/AAMI CN27:2021 General Requirements For Luer Activated Valves (LAVs) Incorporated Into Medical Devices For Intravascular Applications
ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
Power injection flow rate testing (non-standardized test)
USP Bacterial Endotoxin Test

Biocompatibility tests:

ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
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-Acute and Subchroic systemic toxicity
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-Genotoxicity Test
ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
USP NF 2021 chapter Pyrogen Test
USP Particulate matter in injections

Sterility, Shipping, and Shelf-Life tests:

ISO 11135:2014, Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP39
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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.

K170897

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.

Not Found

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

Regulation Number and Section

§ 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).

Summary

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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 8, 2023

Promisemed Hangzhou Meditech Co., Ltd. % Wei Shan Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building 300 Hennessy Road, Hong Kong, Hong Kong CHN

Re: K230715

Trade/Device Name: Promisemed Safety Huber Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: May 11, 2023 Received: May 12, 2023

Dear Wei Shan Hsu:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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.

Alan St

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) K230715

Device Name Promisemed Safety Huber Needle

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 imaging.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X 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

1 Date Prepared

June 8th, 2023

Submitter's Information 2

Name of Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

Address:

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou

City, 311121 Zhejiang, China

Contact Name:

Zearou Yang

Telephone No.:

+86 571 88772985

Fax No.:

+86 571 88772985

Email Address:

zearou.yang@promisemed.ca

ന Trade Name, Common Name, Classification

Trade/Product Name: Promisemed Safety Huber Needle Regulation name: Hypodermic Single Lumen Needle Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: PTI

ldentification of Predicate Device ব
K170897 Surecan Safety II

4

Description of the Device റ

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick 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 patient for 24h to 7 days.

Image /page/4/Figure/5 description: The image shows the code rule for SHU-1919CHY. The last letter "Y" means that it has a Y injection site. The letter "H" means that the tubing is pressure resistant. The other letters represent the type of safety mechanism, needle length, and needle gauge.

Table 1. Model list

Type	Model	Note	Gauge	Color
Type B	SHU-1919B, SHU-1925B, SHU-1938B	NA
	SHU-1919BH, SHU-1925BH, SHU-1938BH	Pressure resistance up to 330 psi
	SHU-1919BY, SHU-1925BY, SHU-1938BY	With Y-injection site	19G	Cream
	SHU-1919BHY, SHU-1925BHY, SHU-1938BHY	Pressure resistance up to 330 psi
with Y-injection site
	SHU-2019B, SHU-2025B, SHU-2038B	NA
	SHU-2019BH, SHU-2025BH, SHU-2038BH	Pressure resistance up to 330 psi
	SHU-2019BY, SHU-2025BY, SHU-2038BY	With Y-injection site	20G	Yellow
	SHU-2019BHY, SHU-2025BHY, SHU-2038BHY	Pressure resistance up to 330 psi
with Y-injection site
	SHU-2219B, SHU-2225B, SHU-2238B	NA
	SHU-2219BH, SHU-2225BH, SHU-2238B	Pressure resistance up to 330 psi
	SHU-2219BY, SHU-2225BY, SHU-2238BY	With Y-injection site	22G	Black
	SHU-2219BHY, SHU-2225BHY, SHU-2238BHY	Pressure resistance up to 330 psi
with Y-injection site
Type C	SHU-1919C, SHU-1925C, SHU-1938C	NA	19G	Cream

5

SHU-1919CH, SHU-1925CH, SHU-1938CH	Pressure resistance up to 330 psi
SHU-1919CY, SHU-1925CY, SHU-1938CY	With Y-injection site
SHU-1919CHY, SHU-1925CHY, SHU-1938CHY	Pressure resistance up to 330 psi
with Y-injection site
SHU-2019C, SHU-2025C, SHU-2038C	NA
SHU-2019CH, SHU-2025CH, SHU-2038CH	Pressure resistance up to 330 psi
SHU-2019CY, SHU-2025CY, SHU-2038CY	With Y-injection site	20G	Yellow
SHU-2019CHY, SHU-2025CHY, SHU-2038CHY	Pressure resistance up to 330 psi
with Y-injection site
SHU-2219C, SHU-2225C, SHU-2238C	NA
SHU-2219CH, SHU-2225CH, SHU-2238CH	Pressure resistance up to 330 psi
SHU-2219CY, SHU-2225CY, SHU-2238CY	With Y-injection site	22G	Black
SHU-2219CHY, SHU-2225CHY, SHU-2238CHY	Pressure resistance up to 330 psi
with Y-injection site

Image /page/5/Figure/3 description: The image shows two different types of Huber Needles, labeled as Type B and Type C. Type B has a wing hub and a protective shield, with the Huber Needle extending downwards. Type C also has a wing hub and a protective shield, but the design is more rounded compared to Type B, with the Huber Needle extending downwards as well.

6 Indication

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.

6

7 Similarities and Differences of the Proposed Devices to the Predicate Devices

The Promisemed Safety Huber Needle is substantially equivalent to the predicate device, Surecan Safety II (K170897) in that these devices have similar intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not raise new questions of safety and effectiveness.

| | Subject Device | Predicate Device
(K170897) | |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed Safety
Huber Needle | Surecan Safety II | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | B. Braun Medical Inc | |
| Device Class | Class II | Class II | Same |
| Product Code | PTI | PTI | Same |
| Regulation number | 880.5570 | 880.5570 | Same |
| Regulation Name | Hypodermic Single
Lumen Needle | Hypodermic Single
Lumen Needle | Same |
| Intended Use | It is used to access
surgically implanted
vascular ports and is
indicated for use in the
administration of fluids
and drugs. | Access surgically
implanted vascular ports
for the infusion of fluids,
drugs, and blood
sampling | Similar¹
The subject
device is not
intended for blood
sampling. |
| 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 | The Surecan Safety II
power-injectable safety
non-coring needle is a
device intended for
insertion into the
septum of a
subcutaneously
implanted port for the
infusion of fluids and
drugs, as well as blood
sampling through the
port. The Surecan Safety
II safety feature is
manually activated
during needle removal,
and is designed to aid in
the prevention of
accidental needle-sticks. | Similar²
The subject
device is not
intended for blood
sampling. |
| | 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. | When used with ports
that are indicated for
power injection of
contrast media into the
central venous system,
the Surecan Safety II
needle is also indicated
for power injection of
contrast media. | |
| Safety Mechanism
Design | Manually activated
safety mechanism upon
removal of the needle
from the implanted
vascular port. | Manually activated
safety mechanism upon
removal of the needle
from the implanted
vascular port. | Similar 3
The subject
device has
additional type of
safety mechanism |
| | Safety mechanism either
have a protective shield
cover the needle tip
(Type B, figure1) or locks
needle into place when a
firm stop is felt (Type C). | Safety mechanism locks
needle into place when a
firm stop is felt.
A green dot appears on
the clear bottom plate
when safety mechanism
is fully engaged. | (Type B, refer to
Table1 and Figure

A detailed comparison to the predicate is provided in Table 1.

7

8

9

Discussions of differences in technological characteristics

The subject device has the similar intended use, indications for use, technological characteristics, safety mechanism design when compared to the predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices.

Note 1 and 2: The subject device is not intended for blood sampling, this difference does not affect the substantial equivalence of the device.

Note 3: The subject device has additional type of safety mechanism (Type B, Figure 1) to protect against sharps injury. The sharps protection feature is addressed through testing per ISO23908.

Note 4: The needle length of subject device is within the range of predicate device. The difference needle length does not affect the substantial equivalence of the device.

Note 5: The "H" subtype (refer to Table 1) of subject device withstands power injection pressures of 330 psi, which is higher than predicate device. The flow rate under 330 psi has been verified.

Note 6 and 7: The biocompatibility tests conducted demonstrated the safety of subject device.

Note 8: The subject device meets the requirements of FDA recognized standards.

The differences above do not impact the substantial equivalence of the device.

Performance Testing Summary 8

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

10

ISO 8536-4 :2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
· ISO 23908:2011, Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
· ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
ANSI/AAMI CN27:2021 General Requirements For Luer Activated Valves (LAVs) Incorporated Into Medical Devices For Intravascular Applications
ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
· Power injection flow rate testing (non-standardized test)
USP Bacterial Endotoxin Test

Biocompatibility

In accordance with ISO 10993-1 the device is classified as External communicating device, in contact with circulating blood with prongled duration. The biosafety tests that required consideration were validated:

ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
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-Acute and Subchroic systemic toxicity
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-Genotoxicity Test

11

ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
· ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
USP NF 2021 chapter Pyrogen Test
· USP Particulate matter in injections
Sterility, Shipping, and Shelf-Life
· ISO 11135:2014, Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
· Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP39
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
の Conclusion

Based on the information provided within this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.