Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and fluid dynamics of IV sets and accessories, with no mention of AI or ML.

Therapeutic

No
The devices are for the administration of fluids, drugs, antibiotics, etc., into the patient's vascular system. While these administered substances may be therapeutic, the device itself is a fluid administration set and accessories, not directly acting as a therapeutic agent.

Diagnostic

No

The device is an IV extension set used for administering fluids, not for diagnosing medical conditions. Its function is to deliver substances to the patient, not to analyze, detect, or monitor physiological parameters for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like tubing, clamps, luers, and valves, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the "administration of fluids from a container into the patient's vascular system". This describes a device used on the patient for therapeutic or supportive purposes, not for testing samples from the patient to diagnose a condition.
Device Description: The description details components like tubing, luers, clamps, and valves, all designed for fluid delivery. It also mentions accessories like anti-siphon valves and filters, which are also related to fluid administration and safety. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Using reagents or calibrators

The device described is a standard medical device used for delivering fluids intravenously.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

Product codes

FPA, FPB

Device Description

The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe.

The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient.

The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system

Indicated Patient Age Range

Not Found

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 following bench tests were conducted to evaluate the functional performance of the proposed devices:

ISO 80369-7 Luer Tests on male Luer Lock Connector
ISO 80369-7 Luer Tests on female Luer Lock Connector
Tensile Strength Test
Leak Test
Counter Flow Test
Blocking Performance Test
Opening Pressure Test
Notch Clamp Activation Force Test
Notch Clamp Shut-Off Test
Filter Tests
Non-DEHP Claim Verification ( on the proposed devices subject to this premarket notification. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

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

Not Found

Predicate Device(s)

K112893

Reference Device(s)

K113227

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Summary

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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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 20, 2020

Baxter Healthcare Corporation Gary Chumbimune Associate Director, Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073

Re: K192366

Trade/Device Name: Intravascular Extension Sets and Accessories Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, FPB Dated: June 16, 2020 Received: June 19, 2020

Dear Gary Chumbimune:

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

1

requirements, including, but not limited to: registration and listing (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 (OS) 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-devices/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 (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 Payal Patel Acting 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) K192366

Device Name

Intravascular Extension Sets and Accessories

Indications for Use (Describe)

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

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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Image /page/3/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and has a slightly italicized appearance. The word is the logo for the healthcare company Baxter International.

510(k) Summary-K192366

July 20, 2020

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Gary Chumbimune Associate Director, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270 3312 Fax: (224) 270 4119

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Intravascular Extension Sets and Accessories Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name : Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA, FPB

Code #	Device Description
2N335
4	Micro-Volume Extension Set, 79" (200 cm), Vol 0.47 mL

1: Non-Vented Cap
2: Female Luer Lock
3: Notch Clamp
4: Tubing
5: Male Luer Lock
6: Male Luer Cap

Table 1. Proposed IV Extension Set Configurations

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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is in blue and appears to be a logo. The letters are evenly spaced and the overall design is simple and modern. The image is clear and well-defined.

Code #	Device Description
2N338
0	Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL
Image: [Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL]	1: Non-Vented Cap
2: Female Luer
Lock
3: Notch Clamp
4: Tubing
5: Male Luer Lock
6: Male Luer Cap
2N335
8	Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL
Image: [Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL]	1: Non-Vented Cap
2: Female Luer
Lock
3: Tubing
4: Male Luer Lock
5: Male Luer Cap
2N335
7	Micro-Volume Extension Set with 0.2 µm Filter, 79" (200 cm), Vol 0.88 mL
Image: [Micro-Volume Extension Set with 0.2 µm Filter, 79" (200 cm), Vol 0.88 mL]	1: Non-Vented Cap
2: Female Luer
Lock
3, 6: Tubing
4: 0.2µm Filter
5: Notch Clamp
7: Male Luer Lock
8: Male Luer Cap
2N338
2	Micro-Volume Extension Set with 0.2 µm Filter, 59" (150 cm), Vol 0.75 mL
Image: [Micro-Volume Extension Set with 0.2 µm Filter, 59" (150 cm), Vol 0.75 mL]	1: Non-Vented Cap
2: Female Luer
Lock
3, 6: Tubing
4: 0.2µm Filter
5: Notch Clamp
7: Male Luer Lock
8: Male Luer Cap
2N338
6	Micro-Volume Catheter Extension Set with 0.2 µm Filter, 10" (25 cm), Vol 0.44 mL
Image: [Micro-Volume Catheter Extension Set with 0.2 µm Filter, 10" (25 cm), Vol 0.44 mL]	1: Non-Vented Cap
2: Female Luer
Lock
3, 6: Tubing
4: 0.2µm Filter
5: Notch Clamp
7: Male Luer Lock
8: Male Luer Cap
2N335
5	Mini-Volume Extension Set, 59" (150 cm), Vol 0.91 mL
Image: [Mini-Volume Extension Set, 59" (150 cm), Vol 0.91 mL]	1: Non-Vented Cap
2: Female Luer
Lock
3: Notch Clamp
4: Tubing

Table 1. Proposed IV Extension Set Configurations

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Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The font is sans-serif and the letters are evenly spaced.

Image /page/5/Figure/1 description: The image shows a table with different medical devices and their descriptions. The first device is a Mini-Volume Extension Set, 79" (200 cm), Vol 1.1 mL, with code 2N335 6. The second device is a Mini-Volume Extension Set, 118" (300 cm), Vol 1.4 mL, with code 2N335 9. The third device is a Polyethylene (PE) Lined Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL, with code 2N336 0.

Table 1. Proposed IV Extension Set Configurations

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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and has a slightly italicized appearance. The word is the logo for the healthcare company Baxter International.

Code #	Device Description
2N3364	Anti-Siphon Valve, Vol 0.24 mL
Image: Anti-Siphon Valve	1: Non-Vented Cap to Female Luer
2: Anti-Siphon Valve
3: Touch Contamination Protector
2N3365	Back Check Valve, Vol 0.28 mL
Image: Back Check Valve	1: Non-Vented Cap to Female Luer
2: Back Check Valve
3: Touch Contamination Protector
2N3368	Air-Eliminating 1.2 μm Solution Filter, Vol 0.80 mL
Image: Air-Eliminating 1.2 μm Solution Filter	1: Non-Vented Cap to Female Luer
2: 1.2 μm Filter
3: Touch Contamination Protector

Table 2. Proposed IV Set Accessories

PREDICATE DEVICE:

Table 3. Predicate De vice

Device	Company	Predicate 510(k)
Clearlink Luer
Activated Valve,
Clearlink SystemNon-
DEHP Catheter
Extension Sets	Baxter Healthcare
Corporation	K112893	October 18, 2011

REASON FOR SUBMISSION:

The basis for this premarket notification is the intend to market Intravascular (IV) Extension Sets and Accessories. The proposed devices in this submission are single-use, disposable devices, intended for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly italicized. The word is likely a logo or brand name.

DESCRIPTION OF THE DEVICE:

The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe.

The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient.

The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.

INDICATIONS FOR USE:

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices are substantially equivalent to the predicate device, previously cleared under 510(k) premarket notification K112893 on October 18, 2011. The intended use and function of the proposed devices are equivalent to the predicate device.

Table 4 is a device comparison table outlining the differences between the predicate and proposed devices.

| Features | Predicate Device
Cleared under
K112893 | Proposed Devices | Assessment of Differences |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use with a vascular
access device for the
administration of drugs
and solutions. The
Clearlink Luer
Activated Valve is an
in-line injection site. | For the administration
of fluids from a
container into the
patient's vascular
system through a
vascular access device. | Same
Minor rewording of the Intended
Use statement has been made to
better align with 21 CFR
880.5440 and for the purpose of |
| | Predicate Device
Cleared under
K112893 | Proposed Devices | Assessment of Differences |
| Features | which can be
connected to the
standard male Luer
adapters (e.g., syringes
or sets) for continuous
or intermittent fluid
administration or the
withdrawal of fluid. | | streamlining the information
provided to the user.
The general purpose of the
device and its function remain
unchanged.
The minor rewording of the
Intended Use statement does not
raise different questions of safety
and effectiveness. |
| Indication for
Use | For use with a vascular
access device for the
administration of drugs
and solutions. The
Clearlink Luer
Activated Valve is an
in-line injection site,
which can be
connected to the
standard male Luer
adapters (e.g., syringes
or sets) for continuous
or intermittent fluid
administration or the
withdrawal of fluid. | For the administration
of fluids from a
container into the
patient's vascular
system through a
vascular access device. | Same
Minor rewording of the
Indications for Use statement has
been made to better align with 21
CFR 880.5440 and for the
purpose of streamlining the
information provided to the user.
This minor modification does not
alter the disease or condition the
device will diagnose, treat,
prevent, cure/mitigate, or the
patient population for which the
device is intended to be used. In
addition, the minor rewording
does not reflect a different
anatomical site from which a
disease state or population may
be inferred.
The minor rewording of the
Intended Use statement does not
raise different questions of safety
and effectiveness. |
| Sterile | Yes | Same | N/A |
| Non-
Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Fluid path Components/Materials | | | |
| Anti-Siphon
Valve | Not Applicable | Polymethyl
methacrylate (Acrylic)
[Female and Male Luer]
Silicone (Membrane) | The predicate device does not
have an anti-siphon check valve.
Design control activities have
been conducted and have
confirmed that the different
technological characteristics of
the proposed devices do not raise |
| Features | Predicate Device
Cleared under
K112893 | Proposed Devices | Assessment of Differences |
| Back Check
Valve | Not Applicable | (2N3364)
Polymethyl
methacrylate (Acrylic)
[Female and Male Luer]
Silicone (Membrane)
(2N3365) | different questions of safety and
effectiveness
The predicate device does not
have a check valve. Design
control activities have been
conducted and have confirmed
that the different technological
characteristics of the proposed
devices do not raise different
questions of safety and
effectiveness |
| 0.2 μm Filter | Not Applicable | Polymethyl
methacrylate (Acrylic)
[Housing]
Polyvinylidene fluoride
(Air Vent Membrane)
Polyethersulfone
(Solution Membrane)
(2N3382, 2N3357,
2N3386) | The predicate device does not
have a 0.2 μm Filter. These
materials have been used in
another Baxter cleared device
(cleared in K113227, 12/08/11)
with the same/similar intended
use and with the same type and
duration of contact. Design
control activities have been
conducted and have confirmed
that the different technological
characteristics of the proposed
devices do not raise different
questions of safety and
effectiveness. |
| Air-
Eliminating
1.2 μm
Solution Filter | Not Applicable | Polymethyl
methacrylate (Acrylic)
[Housing]
Polytetrafluoroethylene
(Air Vent Membrane)
Polyethersulfone
(Solution Membrane)
(2N3368) | The predicate device does not
have a 1.2 μm Filter. Design
control activities have been
conducted and have confirmed
that the different technological
characteristics of the proposed
devices do not raise different
questions of safety and
effectiveness. |
| Tubing | Polyvinyl Chloride
(2N8374) | Same
(2N3358, 2N3380,
2N3354, 2N3382,
2N3357, 2N3355,
2N3356, 2N3359,
2N3386) | N/A |
| Features | Predicate Device
Cleared under
K112893 | Proposed Devices | Assessment of Differences |
| Tri-Layer
Tubing | Not Applicable | Low-Density
Polyethylene

Ethylene vinyl acetate

Polyvinyl chloride

(2N3360, 2N3361,
2N3362) | The predicate device does not
have the same type of material
formulation. Design control
activities have been conducted
and have confirmed that the
different technological
characteristics of the proposed
devices do not raise different
questions of safety and
effectiveness. |
| Female Luer
Lock | Copolyester
(2N8374) | Polymethyl
methacrylate (Acrylic)

(2N3358, 2N3380,
2N3354, 2N3382,
2N3357, 2N3355,
2N3356, 2N3359,
2N3360, 2N3361,
2N3362, 2N3386) | The predicate device does not
have the same type of material
formulation. Design control
activities have been conducted
and have confirmed that the
different technological
characteristics of the proposed
devices do not raise different
questions of safety and
effectiveness. |
| Male Luer
Lock | Acrylonitrile
Butadiene Styrene
(2N8374) | Same
(2N3358, 2N3380,
2N3354, 2N3382,
2N3357, 2N3355,
2N3356, 2N3359,
2N3360, 2N3361,
2N3362, 2N3386) | N/A |
| Male Luer
Cap | Polypropylene
(2N8374) | High Density
Polyethylene (Cap)

Hydrophobic Filter,
Acrylic (W/Non-Woven
Nylon Substrate) (Filter
Membrane)

(2N3358, 2N3380,
2N3354, 2N3382,
2N3357, 2N3355,
2N3356, 2N3359,
2N3360, 2N3361,
2N3362, 2N3386) | The predicate device does not
have the same type of material.
Design control activities have
been conducted and have
confirmed that the different
technological characteristics of
the proposed devices do not raise
different questions of safety and
effectiveness. |

Table 4. Device Comparison

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Table 4. Device Comparison

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Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.

Table 4. Device Comparison

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Table 4. Device Comparison

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DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

Performance Data:

The following bench tests (Table 5) were conducted to evaluate the functional performance of the proposed devices:

Test	Acceptance Criteria
ISO 80369-7 Luer Tests on male Luer Lock Connector	BS EN ISO 80369-7:2016, Clause 6.1.2,
BS EN ISO 80369-7:2016, Clause 6.1.3,
ISO 80369-7:2016, Clause 6.2,
ISO 80369-7:2016, Clause 6.3,
ISO 80369-20:2015 AnnexE,
ISO 80369-7:2016, Clause 6.1.2,
ISO 80369-7:2016, Clause 6.1.3,
ISO 80369-7:2016, Clause 6.4,
ISO 80369-7:2016, Clause 6.5,
ISO 80369-7:2016, Clause 6.6,
ISO 80369-7: 2016, Clause 5,
ISO 594-1:1986, Clause 3,
ISO 594-2:1998, Clause 3 (as applicable)
ISO 80369-7 Luer Tests on female Luer Lock
Connector	BS EN ISO 80369-7:2016, Clause 6.1.2,
BS EN ISO 80369-7:2016, Clause 6.1.3,
ISO 80369-7:2016, Clause 6.2,
ISO 80369-7:2016 Clause 6.3,
ISO 80369-20:2015 AnnexE,
ISO 80369-7:2016, Clause 6.1.2,
ISO 80369- 7:2016, Clause 6.1.3,
ISO 80369-7:2016, Clause 6.4,
ISO 803697:2016, Clause 6.5.
ISO 80369-7:2016, Clause 6.6,
ISO 80369-7:2016, Clause 5 (as applicable),
ISO 594-1:1986, Clause 3,
ISO 594-2:1998, Clause 3
Tensile Strength Test	BS EN ISO 8536-9, Clause 5.3,
BS EN ISO 8536-10, Clause 4.3,
BS EN ISO 8536-11, Clause 5.3,
BS EN ISO 8536-12, Clause 6.2,
Leak Test	BS EN ISO 8536-9: 2015, Section A.4,
BS EN ISO 8536-11:2015, Section A.4,
ISO 8536-10: 2015, section A.4
Counter Flow Test	ISO 8536-12:2007+A1:2013, Clause A.4.

Table 5. Performance Data

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Test	Acceptance Criteria
Blocking Performance Test	ISO 8536-12:2007+A1:2013, Clause A.6.
Opening Pressure Test	ISO 8536-12:2007+A1:2013, Clause A.7.1
and per Baxter Test Method
Notch Clamp Activation Force Test	Per Baxter Test Method
Notch Clamp Shut-Off Test	ISO 8536-14:2015
Filter Tests	EN ISO 8536-11, Clause 5.1
and per Baxter Test Method
Non-DEHP Claim Verification ( on the proposed devices subject to this premarket notification. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

CONCLUSION:

The non-clinical data demonstrate that the subject devices are substantially equivalent and perform comparably to the predicate device that is legally marketed for the same intended use.