Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a disposable syringe and associated components for injecting contrast media. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on material properties, sterility, and compatibility with injectors, not algorithmic performance.

Therapeutic

No
The device is described as an angiographic syringe intended for the injection of contrast media or saline, which are diagnostic procedures, not therapeutic interventions.

Diagnostic

No

Explanation: The device is a syringe and accessory tubes intended for the injection of contrast media or saline. It is not described as being used for diagnosis, but rather for delivering substances that might aid in diagnostic imaging performed by other devices.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components (disposable syringes, connection tube, J shape tube, and spike) and the performance studies focus on physical properties and compatibility with hardware (injectors). There is no mention of software as the primary or sole component.

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 for the "injection of contrast media or saline." This is a direct administration of substances into the body for imaging purposes, not for testing samples in vitro (outside the body).
Device Description: The description mentions syringes, tubes, and spikes, which are components used for delivering fluids, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances during a medical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline: they shall be used with US legally marketed angiographic injectors.

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

DXT

Device Description

The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.

Syringe: the syringe is intended to be used with an U.S. legally marketed angiography injector. A Compatibility is shown in Table 1.
Connection tube: used to connect the syringe and the catheter. The tubes are also available in various configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe). The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube.
J shape tube: used to draw contrast media/saline into the syringe barrel before the syringe installed.
Spike: used to draw contrast media/saline into the syringe barrel before the syringe installed. The pressure specification for spike is provided in Table 3 Pressure Specifications for Spike

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

The only difference between the subject and the predicate is that the labeling states "Not intended for infant or neonatal use" in the subject device, while predicate device states "Not intended for pediatric or neonatal use." For this modification, EO/ECH residual test has been conducted on the models in this submission and test results have demonstrated EO/ECH residue level meet the residue limit for 10kg children group as per ISO 10993-7. Therefore, this difference will not impact the safety and effectiveness of the device.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

Non-Clinical Test Conclusion: The non-clinical tests for the predicate device in K192657 are applicable for proposed device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-7:2008 (AMD1:2019) Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals;
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials; A
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by A Dye Penetration:
USP 41-NF36 2018 Bacterial Endotoxins Limit;
ISO 7886-1:2017 Sterile hypodermic syringes for single use-Part 1: Syringes for manual use;
ISO 7886-2:1996 Sterile hypodermic syringes for single use --Part 2: Syringes for use with power-driven svringe pumps:
ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General Requirements;
ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock Fitting;
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 10993-4:2017, Biological Evaluation of Medical Device -Part 4: Selection of tests for interactions with blood.
ASTM F756:2017, Standard Practice for Assessment of Hemolytic Properties of Materials
USP 41 NF 36 Pyrogen Test
A 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
USP Particular Matter in Injections
Compatibility Test Report between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meet performance under maximum sustained pressure specification.

Clinical Test Conclusion: No clinical study is included in this submission.

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.

K192657

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

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

October 19, 2021

Shenzhen Boon Medical Supply Co., Ltd Baihan Feng Regulatory Affair Manager No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District Shenzhen, Guangdong 518173 China

Re: K211564

Trade/Device Name: Sterile High-pressure Angiographic Syringes for Single-use Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: August 13, 2021 Received: August 23, 2021

Dear Baihan Feng:

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

1

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 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).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211564

Device Name

Sterile High-pressure Angiographic Syringes for Single-use

Indications for Use (Describe)

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline: they shall be used with US legally marketed angiographic injectors.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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3

K211564 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR

Date of Preparation: 10/19/2021 1.
Sponsor Identification 2.

Shenzhen Boon Medical Supply Co., Ltd.

No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District, Shenzhen, 518173, China

Establishment Registration Number: 3012395857

Contact Person: Baihan Feng Position: Regulatory Affair Manager Tel: +86-755-28638515 Fax: +86-755-28638033 Email: faguibu-feng@szboon.com

1. Identification of Subject Device
  Trade Name: Sterile High-pressure Angiographic Syringes for Single-use;

Common Name: Disposable angiographic syringe

Product Name	Models
Syringe	100101, 100103, 100113, 200101, 200102, 300101,
300105, 100104, 100114, 200103, 300103,100111,
100121, 100124, 200104, 100108, 100118, 100129,
100130,100109, 100119, 200107, 300102, 300108,
300110, 300111, 300112
Connection Tube	400101, 400102, 400103, 600101, 600102, 500105,
500106, 500107, 500108, 400201, 400202, 400203,
600201, 600202, 500101, 500102, 500103, 500104,
500201, 500202, 500203, 500204, 500205, 500206,
500207, 500208
J shape tube	700103
Spike	700101, 700102, 700104-1, 700104-2, 700105-1, 700105-
2, 700106, 700107-1, 700107-2

4

Regulatory Information

Classification Name: Angiographic injector and syringe Classification: II Product Code: DXT; Regulation Number: 21 CFR 870.1650; Review Panel: Cardiovascular;

Indications for Use:

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with US legally marketed angiographic injectors.

Device Description:

The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.

Syringe: the syringe is intended to be used with an U.S. legally marketed angiography injector. A Compatibility is shown in Table 1.

| Model
(Syringe) | Volume (ml) | Type | Resistant liquid
leak pressure
(psi) | Injector |
|--------------------|-------------|-------------|--------------------------------------------|---------------------------------------------------------------------------|
| 100101 | 200ml | Single Shot | 400 | MCT & MCT plus CT, K924116
Vistron CT, K991557
EnVision CT, K934086 |
| 100103 | 200ml | Single Shot | 400 | Stellant-S K182273 |
| 100113 | 200/200ml | Dual Shots | 400 | Stellant-D, K182273 |
| 200101 | 65/65ml | Dual Shots | 300 | Spectris, K935668 |
| 200102 | 65/115ml | Dual Shots | 300 | Solaris MRI, K033247 |
| 300101 | 150ml | Single Shot | 1200 | Mark V, K822536 |
| 300105 | 130ml | Single Shot | 1200 | Mark III & Mark IV, K822536 |
| 100104 | 200ml | Single Shot | 400 | CT 9000 & CT9000 ADV, K912944 |
| 100114 | 200/200ml | Dual Shots | 400 | CT 9000 & CT9000 ADV, K912944 |
| 200103 | 60/60ml | Dual Shots | 300 | Optistar LE, Elite, K073592 |
| 300103 | 150ml | Single Shot | 1200 | ILLUMENA, K963071 |
| 100111 | 200ml | Single Shot | 400 | Empower CT, K071378 |
| 100121 | 200/200ml | Dual Shots | 400 | Empower CT, K071378 |

Table 1 Compatibility between Syringe and Injectors

5

100124	60/100ml	Dual Shots	400	Dual Shot, K052633
200104	60/60ml	Dual Shots	300	Sonic Shot, K091734
100108	200ml	Single Shot	400	Dual shot CT, K062168
100118	200/200ml	Dual Shots	400	Dual shot CT, K133189
100129	125ml	Single Shot	400	CT Optione, K152361
100130	125/125ml	Dual Shots	400	CT Optione, K152361
100109	100ml	Single Shot	400	Dual shot, K062168
100119	100/100ml	Dual Shots	400	Duat shot, K062168
200107	100/100ml	Dual Shots	300	EZEM Empower, K062449
300102	125ml	Single Shot	1200	120S, K092896
300108	150ml	Single Shot	1200	Mark VII, K112086
300110	150ml	Single Shot	1200	Rempress, K092896
300111	150ml	Single Shot	1200	Angiomat 6000, K944875
300112	200ml	Single Shot	1200	Illumena K963071

Connection tube: used to connect the syringe and the catheter. The tubes are also available in various configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe). The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube.

| Model | Maximum
Withstanding
Pressure (psi) | Type |
|--------|-------------------------------------------|----------|
| 400101 | 400 | Straight |
| 400102 | 400 | Type Y |
| 400103 | 400 | Type T |
| 600101 | 400 | Type T |
| 600102 | 400 | Type Y |
| 500105 | 1200 | Straight |
| 500106 | 1200 | Straight |
| 500107 | 1200 | Straight |
| 500108 | 1200 | Straight |
| 400201 | 400 | Straight |
| 400202 | 400 | Type Y |
| 400203 | 400 | Type T |
| 600201 | 400 | Type T |
| 600202 | 400 | Type Y |
| 500101 | 1200 | Straight |
| 500102 | 1200 | Straight |
| 500103 | 1200 | Straight |
| 500104 | 1200 | Straight |
| 500201 | 1200 | Straight |

Table 2 Pressure Specifications for Connection Tube

6

500202	1200	Straight
500203	1200	Straight
500204	1200	Straight
500205	1200	Straight
500206	1200	Straight
500207	1200	Straight
500208	1200	Straight

J shape tube: used to draw contrast media/saline into the syringe barrel before the syringe installed.
Spike: used to draw contrast media/saline into the syringe barrel before the syringe installed. The pressure specification for spike is provided in Table 3 Pressure Specifications for Spike

Table 3 Pressure Specifications for Spike
Model	Maximum
Withstanding
Pressure (psi)	Type
700101	/	Long spike
700102	/	Short spike
700104-
1	400 psi	Single Air Chamber
Transfer Set
700104-
2	400 psi	Single Air Chamber
Transfer Set with
Extension Tube
700105-
1	400 psi	Dual Air Chamber
Tranfer Set
700105-
2	400 psi	Dual Air Chamber
Tranfer Set with
extension tube
700106	/	Transfer Set With C-
Clamp
700107-
1	/	Transfer set with Clave
connector
700107-
2	/	Clave connector Transfer
set with Check valve

Table 3 Pressure Specifications for Spike

1. Identification of Predicate
  Device 510k Number: K192657

Product Name: Sterile High-pressure Angiographic Syringes for Single-use; Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.

ર. Non-Clinical Test Conclusion

7

The non-clinical tests for the predicate device in K192657 are applicable for proposed device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-7:2008 (AMD1:2019) Biological evaluation of medical devices-Part 7: Ethylene oxide > sterilization residuals;
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials; A
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by A Dye Penetration:
USP 41-NF36 2018 Bacterial Endotoxins Limit;
ISO 7886-1:2017 Sterile hypodermic syringes for single use-Part 1: Syringes for manual use;
ISO 7886-2:1996 Sterile hypodermic syringes for single use --Part 2: Syringes for use with power-> driven svringe pumps:
ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General Requirements;
ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock Fitting;
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 10993-4:2017, Biological Evaluation of Medical Device -Part 4: Selection of tests for interactions with blood.
ASTM F756:2017, Standard Practice for Assessment of Hemolytic Properties of Materials
USP 41 NF 36 Pyrogen Test
A 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
USP Particular Matter in Injections >
Compatibility Test Report between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meet performance under maximum sustained pressure specification.
1. Clinical Test Conclusion No clinical study is included in this submission.

| Item | Subject Device | Predicate Device
K192657 | |
|-------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Product Code | DXT | DXT | |
| Regulation Number | CFR 870.1650 | CFR 870.1650 | |
| Indications for Use | Sterile High-pressure
Angiographic Syringes for | Sterile High-pressure
Angiographic Syringes for | |
| | | Single-use are intended for | Single-use are intended for |
| | | the injection of Contrast
media or saline; they shall be | the injection of Contrast
media or saline; they shall be |
| | | used with an US legally | used with an US legally |
| | | marketed angiographic
injectors. | angiographic
marketed injectors. |
| Mode of operation | | Power-driven operation,
single use | Power-driven operation,
single use |
| Configuration | | Angiographic Syringe | Angiographic Syringe |
| | | Connecting tube | Connecting tube |
| | | J shape tube/Spike | J shape tube/Spike |
| Sterility | | EO Sterilized | EO Sterilized |
| Single Use | | Yes | Yes |
| Model | | Same Models | |
| Maximum
withstanding
pressure | Syringe | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi |
| | Connection tube | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi |
| | J shape tube | NA | NA |
| | Spike | 400 psi | 400 psi |
| Specification | Syringe
(Volume, ml) | 200, 150, 125, 130, 100,
200/200, 60/100, 125/125,
100/100, 65/65, 65/115,
60/60, 50/50 | 200, 150, 125, 130, 100,
200/200, 60/100, 125/125,
100/100, 65/65, 65/115,
60/60, 50/50 |
| | Connection
tube (overall
Length, mm) | 200~~2500, 1500~~2500,
1500, 1800, 2000, 2500, 500,
750, 1000, 1200 | 200~~2500, 1500~~2500,
1500, 1800, 2000, 2500, 500,
750, 1000, 1200 |
| | J shape tube
(overall
Length, mm) | 240 | 240 |
| | Spike
(overall
Length, mm) | 58.8, 47.3, 1000, 2800, 1200,
2900, 180, 260, 340, 420,
500, 450, 550, 600 | 58.8, 47.3, 1000, 2800, 1200,
2900, 180, 260, 340, 420,
500, 450, 550, 600 |
| | | | |
| | | | |
| Performance | | | |
| Syringe | | ISO 7886 | ISO 7886 |
| Luer connector | | ISO 594-1; ISO 594-2 | ISO 594-1; ISO 594-2 |
| Compatibility | | Pass | Pass |
| Patient-Contact Material | | | |
| Syringe | Barrel | PP (polypropylene) or PET
(Polyethylene terephthalate) | PP (polypropylene) or PET
(Polyethylene terephthalate) |
| | Piston | Polyisoprene rubber | Polyisoprene rubber |
| | Lubricant | Polydimethylsiloxane | Polydimethylsiloxane |
| | | | |
| Connection
tube | Tubing | PVC (Polyvinylchloride) or
PVC (Polyvinylchloride not
made with DEHP) or PU | PVC (Polyvinylchloride) or
PVC (Polyvinylchloride not
made with DEHP ) or PU |
| | | ( Polyurethane ) | ( Polyurethane ) |
| | Luer
connectors | PC (Polycarbonate) | PC (Polycarbonate) |
| | UV adhesive | Ultraviolet adhesive | Ultraviolet adhesive |
| Spike | Closure-
piercing
device | ABS (acrylonitrile-
butadiene-styrene) | ABS (acrylonitrile-
butadiene-styrene) |
| | Filter
membrane | PP (polypropylene) | PP (polypropylene) |
| | Tube | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) |
| | Luer
Connector | Polycarbonate (PC) | Polycarbonate (PC) |
| | Protective cap | Acrylonitrile-butadiene-
styrene (ABS) | Acrylonitrile-butadiene-
styrene (ABS) |
| J shape tube | tube | PE (Polyethylene) | PE (Polyethylene) |
| Biocompatibility | | No Cytotoxicity | No Cytotoxicity |
| | | No Irritation | No Irritation |
| | | No Sensitization | No Sensitization |
| | | No Pyrogen | No Pyrogen |
| | | No Acute Toxicity | No Acute Toxicity |
| | | No Hemolysis | No Hemolysis |
| Endotoxin Limit | | 20 EU per device | 20 EU per device |
| EO/ECH residue limit | | Limited Contact: ≤ 24h
EO: 0.6mg/ day
ECH: 1.28mg /day
For 10kg patient (Children)
as per ISO 10993-7 | Limited Contact: ≤ 24h
EO: 4 mg/day
ECH: 9 mg/day
For 70kg patient (Adult) ISO
10993-7 |
| Population | | Not intended for infant or
neonatal use | Not intended for pediatric or
neonatal use |
| Shelf life | | 5 years | 5 years |

7. Substantial Equivalence Comparison

8

9

The only difference between the subject and the predicate is that the labeling states " Not intended for infant or neonatal use" in the subject device, while predicate device states "Not intended for pediatric or neonatal use." For this modification, EO/ECH residual test has been conducted on the models in this submission and test results have demonstrated EO/ECH residue level meet the residue limit for 10kg children group as per ISO 10993-7. Therefore, this difference will not impact the safety and effectiveness of the device.

Substantial Equivalence (SE) Conclusion: 8.

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device is Substantially Equivalent (SE) to the predicate device.