The sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
These neria™ multi sets are intended to be used by patients of all ages who have been prescribed subcutaneous infusion of immunoglobulin (IgG) for the treatment of Primary Immunodeficiency Disease (PID).

Device Description

The neria™ multi product is a multisite infusion catheter. The product has a luer lock connector that is designed to be attached to an infusion pump reservoir. The tubing from the luer connector is attached to a furcation or splitter block, which splits the fluid flow into two, three or four subcutaneous Infusion catheters. Each tube that exits the splitter terminates in a subcutaneous catheter with a stainless steel infusion needle set at 90 degrees from an adhesive pad.
The neria™ multi line will include three different needle lengths of 8, 10 and 12 mm. The product is provided with a separate tubing clamp or clamps to enable the user to selectively stop infusion to one or more sites as necessary. The sets are packaged in custom formed blisters sealed with a Sterikraft paper lid and sterilized in a validated EO gas cycle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the neria™ multi Subcutaneous Infusion Set:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a stand-alone clinical study with comprehensive performance metrics. As such, information regarding ground truth establishment, expert qualifications, and specific multi-reader multi-case studies is not present. The "study" here refers to a series of performance tests.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Reported Device Performance/Conformity
Dimensional Tests	Needle length	Conforms to predefined criteria.
	Tubing Length	Conforms to predefined criteria.
Functional Tests	Leak test	Conforms to predefined criteria.
	Flow test	Conforms to predefined criteria.
Pull (Tension) Tests	Furcator - tubing	Conforms to predefined criteria.
	Set base tubing	Conforms to predefined criteria.
	Luer tubing	Conforms to predefined criteria.
	Set base adhesive	Conforms to predefined criteria.
Biological Tests	Biocompatibility Test	Meets the requirements of ISO 10993-1, Biological evaluation of Medical Devices.
Chemical Testing	Drug/Device compatibility test (with Hizentra®)	Conforms to predefined criteria.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample sizes used for each of the performance tests. It states "The devices were tested for the following attributes and conform to all predefined criteria," implying a sample was used, but the quantity is not provided.
- Data Provenance: Not specified. The tests would likely have been conducted in a lab setting by Unomedical A/S (Denmark, given their address). The nature of these tests (dimensional, functional, biological, chemical) inherently makes them lab-based rather than from patient data. Therefore, the concepts of "country of origin of the data" or "retrospective/prospective" as applied to clinical data are not directly applicable here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. For these types of engineering and material performance tests, "ground truth" is typically established by objective measurements against engineering specifications and industry standards (e.g., ISO for biocompatibility). There is no mention of human expert consensus for these specific tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 are typically used for subjective clinical interpretations by experts. The described tests are objective measurements against predefined criteria.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a subcutaneous infusion set, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the described performance tests, the "ground truth" is based on:
  - Defined Engineering Specifications: For dimensional (needle/tubing length), functional (leak/flow), and pull tests, the acceptance criteria are based on pre-established engineering parameters specific to the device's design and intended function.
  - Industry Standards: For biocompatibility, the ground truth is conformity to ISO 10993-1.
  - Predefined Chemical Compatibility Criteria: For drug compatibility, the ground truth relies on the set's ability to maintain integrity and function when exposed to the specified drug (Hizentra®), likely against pre-established chemical and physical stability criteria.
The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, this question is not relevant.

Overall Conclusion from the document:

The provided 510(k) summary focuses on demonstrating that the neria™ multi Subcutaneous Infusion Set is substantially equivalent to existing legally marketed predicate devices (Unomedical Contact™ and MarCal Medical Sub Q Needle infusion set) by showing it shares similar technological characteristics and meets various performance criteria (dimensional, functional, pull, biological, and chemical). The "study" consists of these performance tests, confirming the device's adherence to predefined engineering specifications and relevant industry standards.

Summary

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8.0 510(K) SUMMARY

Date Prepared: January 31, 2012

8.1 SUMMARY OF SAFETY AND EFFECTIVENESS John M. Lindskog Submitted By:

. President Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4320 Leire. Denmark Telephone: + 45 48 16 70 00

8.2 Trade/Proprietary Name: neria™ multi Subcutaneous Infusion Set
Common/Usual Name 8.3
Subcutaneous Infusion Set
Classification Name 8.4

8.5 Classification

. '

Intravascular administration set . Class: II

Panel: 80 Product Code: FPA Cite: 21 CFR 880.5440

8.6 Predicate Devices

The neria™ multi Subcutaneous Infusion Sets are substantially equivalent to the Unomedical Contact™ Subcutaneous Infusion Sets (K945617) and the MarCal Medical Sub Q Needle infusion set (K082818).

8.7 Indication for Use

The sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

8.8 Intended Use

These neria™ multi sets are intended to be used by patients of all ages who have been prescribed subcutaneous infusion of immunoglobulin (IgG) for the treatment of Primary Immunodeficiency Disease (PID).

8.9 Product Description

The neria™ multi line will include three different needle lengths of 8, 10 and 12 mm. The product is provided with a separate tubing clamp or clamps to enable the user to selectively stop infusion to one or more sites as necessary. The sets are packaged in custom formed blisters sealed with a Sterikraft paper lid and sterilized in a validated EO gas cycle.

MAY 3 0 2012

Image /page/0/Picture/22 description: The image contains a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '120395'. The characters are written in a simple, slightly irregular style, typical of handwriting.

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8.10 Technological Characteristics

The neria™ multi Subcutaneous Infusion Sets have the same technological characteristics as the current marketed products.

CHARACTERISTICS	neriaTM multi	contactTM	Sub Q Needleinfusion set
DRUGCOMPATIBILITY/THERAPY	IMMUNE GLOBULINSUBCUTANEOUS(HUMAN)/PID	NONE SPECIFIED	NONE SPECIFIED
NUMBER OFCATHETERS/FURCATIONS	2, 3 AND 4	1 WITH NOFURCATIONS	1, 2, 3 AND 4
CLAMPS PROVIDED	1 OR 2	0	1, 2, 3, OR 4
NEEDLE MATERIAL	STAINLESS STEEL,AISI 304	STAINLESS STEEL,AISI 304	STAINLESS STEEL
NEEDLE LENGTHS	8, 10, 12 mm	6, 8, 10 mm	6, 9, 12, 14 mm
NEEDLE GAUGES	27	27 AND 29	24 AND 27
ANGLE OF INSERTION	90 DEGREESPERPENDICULAR	90 DEGREESPERPENDICULAR	90 DEGREESPERPENDICULAR
FIXATION TO SKIN	ADHESIVE PAD	ADHESIVE PAD	ADHESIVE"BUTTERFLY"
MATERIALS COMPONENTS	SAME AS CONTACTTM	SAME AS NERIATMMULTI	UNKNOWN
STERILIZATION METHOD	ETO	ETO	GAMMA RADIATION

8.11 Performance Data

The devices were tested for the following attributes and conform to all predefined criteria.

8.11.1 Dimensional Tests

8.11.2 Needle length

8.11.3 Tubing Length

8.11.4 Functional Tests

8.11.5 Leak test

8.11.6 Flow test

8.11.7 Pull (Tension) tests

8.11.7.1 Furcator - tubing

8.11.7.2 Set base tubing
8.11.7.3 Luer tubing
8.11.7.4 Set base adhesive
8.11.8 Biological Tests
- Biocompatibility Test meet the requirements of ISO 8.11.8.1 10993-1, Biological evaluation of Medical Devices.
8.11.9 Chemical Testing
- 8.11.9.1 Drug/Device compatibility test - the sets were tested for Drug compatibility with Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, manufactured by CSL Behring

8.12 Conclusion

Unomedical concludes based on the information presented that the new product is substantially equivalent to products currently legally marketed in the USA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Unomedical A/S C/O Lee H. Leichter MBA, RAC President P/L Biomedical 10882 Stonington Avenue Fort Myers, Florida 33913-8414

MAY 3 0 2012

Re: K120395

Trade/Device Name: neria" multi Subcutaneous Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 10, 2012 Received: May 15, 2012

Dear Mr. Leichter:

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. 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.

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Page 2 - Mr. Leichter

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for
Q. Q. Q
@ Founta

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (If Known):

Device Name:

Indications for Use:

neria™ multi infusion set

The sets are intended for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Prescription Use _ ﮯ (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use_ (Per 21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

All C Ay 5/24/12

Division Sign-Off) ivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K120395

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.