Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of a needle and safety sheath, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is a needle intended for subcutaneous fluid injection; it does not provide therapeutic benefit on its own but is a tool for delivering therapeutic substances.

Diagnostic

No

The device is described as a needle for subcutaneous injection of fluid, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical needle with a safety sheath, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
ASCPO Needle Function: The ASCPO Needle is designed for the injection of fluid into the body (subcutaneously). It is a delivery device, not a diagnostic testing device.

The description clearly states its purpose is for "subcutaneous injection of fluid for medical purpose." This is a therapeutic or procedural use, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

The ASCPO Needle is a single lumen needle intended to inject fluids subcutaneously. 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.

The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer-slip and luer-lock syringes. Additionally, after withdrawal of the needle from the body, the needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body below the surface of the skin (subcutaneously)

Indicated Patient Age Range

Adults only

Intended User / Care Setting

Prescription Use

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

For the Simulated Clinical Use Testing, 500 simulated injections were completed. The testing data indicated that no any failure was observed in a test run of 500 devices, so it would be 97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confident that it was no higher than 1.1% based on the statistical data as presented in the Simulated Clinical Use Test Report.
For the Human Factor Study, TDICT SIP Evaluation Forms were completed by 5 enrolled qualified evaluators according to the validation study protocol.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-Clinical Tests Verification Activities, Simulated Clinical Use Study, Human Factor Study.
Sample Size:

Simulated Clinical Use Study: 500 simulated injections.
Human Factor Study: 5 enrolled qualified evaluators.
Standalone Performance:
Simulated Clinical Use Study: No failure observed in 500 devices. 97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confident that it was no higher than 1.1%.
Human Factor Study: ASCPO Needle meets all operation and usability requirements as recommended in TDICT SIP Evaluation plan; labeling is effective and strongly likely to be read; user interface is well understood by potential users without prior education; provides sufficient information and/or is designed as expected by end-users for safe and effective use.
Key Results: The device complies with relevant ISO standards (ISO 23908, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 series, ISO 11135, ISO 11607-1, ASTM D4169, USP) and FDA guidance for sharps injury preventive features.

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.

BD Eclipse™ Needle (K100209)

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 contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.

December 13, 2022

CC Biotechnology Corporation Judy Cheng Regulatory Associate No. 68, Gongye 5th Rd., Annan Dist. Tainan. 709015 Taiwan

Re: K214004

Trade/Device Name: CCBIO ASCPO Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 18, 2022 Received: November 21, 2022

Dear Judy Cheng:

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,

Alan M.
Stevens -S3

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) K214004

Device Name CCBIO ASCPO Needle

Indications for Use (Describe)

The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

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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This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at June 06, 2017.

The assigned 510(k) number is: K214004

1. Submitter's Identifications:

Applicant' Name:	CC Biotechnology Corporation
Address:	No. 68, Gongye 5th Rd., Annan Dist., Tainan City 709015,
Taiwan (R.O.C).
Telephone:	886-6-3845868
Fax:	886-6-3843968
Official Correspondent:	Edgar Yeh
Date Prepared:	November 18, 2022

2. Name of the Device:

Trade/Proprietary Name:	CCBIO ASCPO Needle, model BA-2001
Common Name:	Single Lumen Hypodermic Needle
Classification Regulations:	Needle, Hypodermic, Single Lumen
Class II, 21 CFR 880.5570
Product Code:	FMI
Classification Panel:	General hospital and personal use devices

3 Device Description:

The ASCPO Needle is a single lumen needle intended to inject fluids subcutaneously. 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.

The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer-slip and luer-lock syringes. Additionally, after withdrawal of the needle from the body, the needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

4. Intended Use:

The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose, and used for adults only. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

1. Information of the 510(k) Cleared Device (Predicate Device):
- BD Eclipse™ Needle (K100209). O

The reason for choosing BD Eclipse™ Needle (K100209) as the SE predicate model is because that the new ASCPO Needle and BD Eclipse™ Needle (K100209) have the same claim of indication for use for which both two models are claimed for prescription use of general purpose injection, and are compatible for use with standard luer-slip and luer-lock syringes.

6. Overall comparison table:

ATTRIBUTE /	ASCPO Needle	BD Eclipse™ Hypodermic	Substantial Equivalence(SE)
CHARACTERISTIC	(Submitted Product)	Needle (Predicate Device)	Comparison
'K" numbers	K214004	K100209	No Comment
Manufacturer	CC Biotechnology	Becton Dickison	No Comment
Intended Use	For use in the subcutaneous
injection of fluid for medical
purpose, and used for adults. The
ASCPO Needle is compatible for
use with standard luer slip and luer
lock syringes.	Used 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 Needle with
SmartSlip™ Technology is
compatible for use with standard
luer-slip and luer-lock syringes.	Similar, since they were
designed for general injection
and are compatible for use
with luer-slip and luer-lock
syringes.
Operating
Principle	This device is single lumen needle
intended to inject fluids
subcutaneously and it has a
passive sharps protection feature
that covers the cannula
immediately and permanently after
use	Composed of a typical
hypodermic needle with a
one-piece hub/adapter and
pivoting cover that is connected
to the adapter. When assemble
the plastic clip into the hub, the
clip ensures that the needle is
attached to a luer slip syringe
with sufficient force by the user.
The pivoting safety cover can be
manually rotated forward after
use allowing for secure
encapsulation of the needlepoint
making the product safe for
disposal	Different but not render non-
substantial equivalence,
since new device was tested
and demonstrated to comply
with FDA SIP Guidance and
ISO 23908 standard.
SIP Feature	passive sharps protection feature
that covers the cannula
immediately and permanently after
use	The pivoting safety cover can be
manually rotated forward after
use allowing for secure
encapsulation of the needlepoint
making the product safe for
disposal.	Different but not render non-
substantial equivalence,
since new device was tested
and demonstrated to comply
with FDA SIP Guidance and
ISO 23908 standard.
Connector type	Luer lock and luer slip	Luer lock and luer slip	Similar
Color coding	Per ISO 6009	Per ISO 6009	Similar
Tip configuration	triple sharpened,
non-coring	triple sharpened,
non-coring	Similar
Materials	Hub: Styrene Butadiene
Copolymer
Cap: Polyoxymethylene	Hub: Polypropylene
Cannula: Stainless Steel
Cannula Lubricant: Silicone	Different but no significant
impact on SE comparison.

	Cannula: Stainless Steel	Needle/Safety Shield:
	Cannula Lubricant: Silicone	Polypropylene
	Needle/Safety Shield:
	Polyoxymethylene
	Adhesive: UV Acrylic
Specification	Needle Length: 1/2"	Needle Length: 1/2"- 1 ½	Different but no significant
	Needle Gauge: 27 Gauge	Needle Gauge: 18-30 Gauge	impact on SE comparison.
		Bevel: Regular, Short,
		Intradermal
Packaging	Sterilization pouch	Sterilization pouch	Different but no significant
	Shelf carton	Shelf carton	impact on SE comparison.
	Case carton	Case carton
Functional	ISO 23908:2011	Hub/Needle Bond Strength: Met	Different but no significant
testing	ISO 7864:2016	internal BD specification	impact on SE comparison,
	ISO 9626:2016	Needle Penetration Test: Met	since new device was tested
	ISO 80369-7:2021	internal BD specification	and demonstrated to comply
	Measuring the penetration force:	Needle Shield Removal Forces:	with the related FDA
	Meet internal CCBio specification	Met internal BD specification	recognized ISO standards
		Leak Testing: Per ISO 594-2
Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Similar
SAL Level	SAL 10-6	SAL 10-6	Similar
Shelf Life	3 Years	5 Years	Different but no significant
			impact on SE comparison.
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Similar
Used as Rx or	Rx(Prescription Use)	Rx(Prescription Use)	Similar
OTC

4

5

7. Comparison to the 510(k) Cleared Device (Predicate Device):

As per reasons for choosing BD Eclipse™ Needle (K100209), we conducted further comparison as follows :

● Comparison of Indication for use.

Based on this, the comparison for the indication for use between new and predicate model was provided hereafter.

| Model | ASCPO Needle
(Submitted Product) | BD Eclipse™ Hypodermic Needle (Predicate Device) |
|---------------------|-------------------------------------|--------------------------------------------------|
| 510(k) No. | K214004 | K100209 |
| Prescription or OTC | Prescription | Prescription |

6

| Indication for use | For use in the subcutaneous
injection of fluid for medical
purpose. The ASCPO Needle is
compatible for use with standard
luer slip and luer lock syringes. | Used 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 Needle with
SmartSlip™ Technology is
compatible for use with standard
luer slip and luer lock syringes. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA product code | FMI | FMI |

Brief comparison result:

Based on comparison information as above mentioned, it is very clear that the "Indication for Use" for the new devices and 510(k) cleared devices are considered as "Substantially Equivalent", even though the Indication for use statement is not completely identical. The determination of substantial equivalence in indication for use is because of the following reasons:

1> Both these two models were designed for "general purpose injection"
2> Both these two models were claimed for "Prescription Use"
3> Both these two models were classified as FDA "FMI" product code.
4> Both these two models were compatible for use with standard luer slip and luer lock syringes.

7

O Comparison of the Technology Aspect.

The comparison for the technology aspect between new and predicate model was as the
following table.

| Model | ASCPO Needle
(Submitted Product) | BD EclipseTM Hypodermic
Needle (Predicate Device) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K214004 | K100209 |
| Operation
principle | This device is single lumen needle
intended to inject fluids
subcutaneously and it has a passive
sharps protection feature that
covers the cannula immediately and
permanently after use | When assemble the plastic clip into
the hub, the clip ensures that the
needle is attached to a luer slip
syringe with sufficient force by the
user. The pivoting safety cover can
be manually rotated forward after
use allowing for secure
encapsulation of the needlepoint
making the product safe for disposal |
| SIP feature | passive sharps protection feature
that covers the cannula immediately
and permanently after use | The pivoting safety cover can be
manually rotated forward after use
allowing for secure encapsulation of
the needlepoint making the product
safe for disposal. |
| Compliance
standard | ISO 23908 & FDA guidance for SIP | ISO 23908 & FDA guidance for SIP |

Brief comparison result:

In the actual device construction, there may be some in the SIP mechanism, namely K100209 is an activate type safety needle, but ASCPO Needle is a passive type safety needle. However, the SIP feature for both models was designed according to ISO 23908 standard and FDA Specific guidance for SIP feature. Therefore, we concluded that the ASCPO Needle is substantially equivalent with BD Eclipse™ Hypodermic needle(K100209) in the main technology aspect.

8

8. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of the devices is as follows:

Biocompatibility has been tested according to the requirements of ISO10993-1. In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, following biocompatibility tests were performed on the finished device to evaluate: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity and Hemolvsis

The sterility of the ASCPO Needle is assured by using a validated sterilization method which complies with the requirements of the FDA Recognized Consensus Standard: ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices. Ethylene oxide (EO) and Ethylene Chlorohydrin (ECH) residuals were tested according to ISO 10993-7: 2008 and met the acceptance criteria.

Meanwhile ASCPO Needle was tested to demonstrate to comply with the following standards: - ISO 23908:2016 "Sharp Injury protection- Requirements and test methods - SIP features for single use hypodermic needles,

ISO 7864:2016 "Requirements and test methods Sterile hypodermic needles for single use".
ISO 9626:2016 "Stainless steel needle tubing for the manufacture of medical devices.
ISO 80369-7:2021 "Small-bore connectors for liquids and gases in healthcare applications. Part 7: Connectors for intravascular or hypodermic applications."
ISO 10993-10: 2010 "Biological evaluation of medical devices Part 10: Tests for skin Sensitization."
ISO 10993-11: 2017 "Biological evaluation of medical devices Part 11: Tests for systemic toxicity."
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."
USP: 2020 "Pvrogen test."
ISO 11135: 2014 "Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices."
ISO 11607-1: 2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems,"
ASTM D4169-16 "Standard Practice for Performance Testing of Shipping Containers and Systems."
USP 788" Particulate Matter in Injections "

Standard	Test Performed
ISO 7864: 2016	Cleanliness
	Limits for acidity or alkalinity
	Limits for extractable metals
	Size designation
	Color coding
	Conical fitting (per ISO 80369-7: 2021)
	Effective needle length
	Lubricant
	Needle point
	Bond between hub and needle tube
	Patency of lumen
	Sharps injury protection (per ISO 23908: 2011)
	Sterility
	Biocompatibility
ISO 9626: 2016	Surface finish and visual appearance
	Cleanliness
	Limits for acidity or alkalinity
	Stiffness
	Resistance to breakage
	Resistance to corrosion
ISO 80369-7: 2021	Leakage by pressure decay
	Sub-atmospheric pressure air leakage
	Stress cracking
	Resistance to separation from axial load
	Resistance to separation from unscrewing
	Resistance to overriding
ISO 23908: 2011	Testing access to the sharp in safe mode
	Security of safe mode protection
	Challenging the device in safe mode
	Testing simulated clinical use
ISO 10993-10: 2010	Tests for skin sensitization
ASTM F756-17	Standard Practice for Assessment of Hemolytic Properties of
	Materials
ISO 10993-11: 2017	Tests for systemic toxicity
ISO 10993-5: 2009	Tests for in vitro cytotoxicity
USP: 2020	Pyrogen test
ISO 11135: 2014	Validation and routine control of a sterilization process for medical
	devices
ISO 10993-7: 2008	Ethylene oxide sterilization residuals
ISO 11607-1	Tests for materials, sterile barrier systems and packaging
	systems.
ASTM D4169-22	Performance Testing of Shipping Containers and Systems.
USP 788	Particulate Test

The tests completed under each standard as shown in the table below:

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Additionally, the shelf-life validation reports were also included in the submission to demonstrate that the ASCPO Needle is adequate for use as claimed 3 years life time.

Discussion: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device.

10

Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.

9. Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device is as follows:

The Simulated Clinical Use Study and Human Factor Study were conducted and performed according to the method as recommended in the FDA specific guidance, entitle "Medical Devices with Sharps Injury Preventive Features".

For the Simulated Clinical Use Testing, 500 simulated injections were completed. The testing data indicated that no any failure was observed in a test run of 500 devices, so it would be 97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confident that it was no higher than 1.1% based on the statistical data as presented in the Simulated Clinical Use Test Report. This testing result complies with the acceptance requirement as specified in the FDA guidance for SIP features as above mentioned.

For the Hunan Factor Study, TDICT SIP Evaluation Forms were completed by 5 enrolled qualified evaluators according to the validation study protocol. The investigation results demonstrated that the ASCPO Needle meets all the operation and usability requirements as recommended in TDICT SIP Evaluation plan, the labeling is effective and strongly likely to be read, that the user interface is well understood by potential user without prior education, and that it provides sufficient information and/or is designed as expected by end-users for a safe and effective use of the device.

10. Summary for the technology comparison.

Based on the evidence conducted and completed for the non-clinical and clinical test validation activities as above mentioned, we draw up the summary that the ASCPO Needle was designed, manufactured, verified and validated to comply with the main technology requirements as specific FDA guidance, entitle "Medical Devices with Sharps Injury Preventive Features" as well as the product related FDA recognized standards namely ISO 10993-1 & related biocompatibility test standards, ISO 11135, ISO 23908, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993-10, ISO 10993-11, ISO 10993-5, ISO 10993-7, USP, ISO 11135, ISO 11607-1, ASTM D4169-22 and USP 788.

Therefore, we concluded that the ASCPO Needle new device is substantially equivalent to the predicate device in the technology aspect.

11. Conclusions

The details of assessments and testing as above mentioned were included in the whole package of this 510(k) submission. Through the detailed assessments and testing as mentioned above, we believe we have provided sufficient information to prove "SE" (Substantial Equivalence) for the ASCPO Needle new device and the chosen predicate devices as mentioned in this 510(k) summary.