The Freedom60 Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®. Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.

The Freedom60 Infusion System with the Freedom60® Infusion Pump and Precision Flow Rate Tubing™ is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, oxacillin, and tobramycin.

The Freedom60 Infusion System consists of the following devices:

Freedom60® Infusion Pump
Precision Flow Rate Tubing
High-Flo Subcutaneous Needle Sets
HigH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, lmmune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)

The Freedom60 Infusion System is indicated for use with the following syringes:

· BD® 50 ml syringe
· Medline® 60 ml Syringe
· Hizentra® 50 ml Prefilled Syringe

Device Description

The Freedom60 Infusion System is a non-powered infusion system that includes a mechanical infusion pump, subcutaneous needle sets, and tubing sets. The infusion pump exerts a constant force on the medication through the tubing. The tubing set and needle set produce a certain amount of resistance, which moderates the flow rate. The tubing sets and needle sets are provided in a range of sizes and device options (number of needle gauge, tubing diameter, etc). The healthcare provider prescribes the tubing/needle sets based on the intended flow rate and dosage of the drug being administered.

The infusion pump is compatible with specific syringe types. An adapter is included as part of this submission to enable compatibility with certain pre-filled syringes that are compatible for use with the Freedom60 infusion system are the BD 50ml syringe, the Medline 60 ml syringe, and the Hizentra 50 ml pre-filled syringe.

The infusion pump and pre-filled syringe adapter are reusable. The infusion sets are are terminally sterilized via gamma radiation. The Freedom60 Infusion System is manufactured from materials with an established history of biological safety, and is not manufactured with latex or natural rubber.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Freedom60 Infusion Pump and associated components). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain information about the specific acceptance criteria, reported device performance in a table, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these typically relate to AI/ML device submissions.

The document refers to mechanical/fluidic performance testing for an infusion pump, not an AI/ML diagnostic system. Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document.

For context, I will outline the information that would be present if this were an AI/ML device submission, and then explain why it's not applicable here based on the provided text.

Information NOT available in the provided document (as it's not an AI/ML device):

Table of acceptance criteria and reported device performance: This document refers to flow rate verification, reliability/use life verification, dose accuracy, and fitment. It does not provide a table with specific numerical acceptance criteria (e.g., minimum sensitivity, specificity) and corresponding achieved performance metrics (e.g., actual sensitivity, specificity values), which are common for AI/ML diagnostic devices.
Sample sizes used for the test set and data provenance: The document mentions "non-clinical testing" and "verification and validation testing" but does not specify sample sizes in terms of patient cohorts or image sets, nor does it mention data provenance (e.g., country of origin, retrospective/prospective), as would be detailed for AI/ML models.
Number of experts used to establish the ground truth for the test set and their qualifications: This is irrelevant here because the device is a mechanical infusion pump. Ground truth for an AI/ML diagnostic device usually involves expert annotations (e.g., radiologists, pathologists).
Adjudication method for the test set: Not applicable, as there's no diagnostic ground truth being established by experts.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies evaluate the impact of AI on human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no standalone AI algorithm.
The type of ground truth used: For this device, the "ground truth" would be established through engineering measurements of flow rates, dose accuracy, and mechanical reliability against design specifications, not clinical outcomes, pathology, or expert consensus on medical images/data.
The sample size for the training set: Not applicable, as this describes a device that undergoes physical manufacturing and testing based on engineering principles, not an AI/ML model that is trained on a dataset.
How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does state about testing:

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7) states:

Testing Performed:
- Flow rate verification
- Reliability/use life verification
- Dose accuracy and fitment
- Human factors validation (per IEC 62366-1 and FDA Guidance)
Clinical Testing: "Clinical testing is not applicable for this submission." This further confirms it's not an AI/ML diagnostic.
Conclusion: "All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process."

In summary, the provided document details the regulatory clearance of a mechanical infusion system, not an AI/ML-driven device. Therefore, the specific acceptance criteria and study details relevant to AI/ML performance (such as sensitivity, specificity, expert ground truth, MRMC studies) are not present and cannot be extracted.

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 3, 2023

Koru Medical Systems Emily DiMambro Senior Regulatory Affairs Specialist 100 Corporate Dr Mahwah, New Jersey 07430

Re: K231918

Trade/Device Name: Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing: High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN, PKP, FPA Dated: October 5, 2023 Received: October 5, 2023

Dear Emily DiMambro:

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 (the 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 available 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

{2}------------------------------------------------

Sincerely,

Jake K. Lindstrom -S

Jake Lindstrom, Ph.D. 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

{3}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

Device Name

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets: Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter

Indications for Use (Describe)

The Freedom60 Infusion System consists of the following devices:

Freedom60® Infusion Pump
Precision Flow Rate Tubing
High-Flo Subcutaneous Needle Sets
HigH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, lmmune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)

The Freedom60 Infusion System is indicated for use with the following syringes:

· BD® 50 ml syringe
· Medline® 60 ml Syringe
· Hizentra® 50 ml Prefilled Syringe

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

510(k) Summary

Prepared on: 2023-06-29

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Koru Medical Systems
Applicant Address	100 Corporate Dr. Mahwah NJ 07430 United States
Applicant Contact Telephone	240-506-3474
Applicant Contact	Ms. Emily DiMambro
Applicant Contact Email	edimambro@korumedical.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Freedom60 Infusion Pump;High-Flo Subcutaneous Needle Sets;Precision Flow Rate Tubing;High-Flo Super26 Subcutaneous Needle Sets;Freedom60 Pre-Filled Syringe Adapter
Common Name	Infusion Pump
Classification Name	Pump, Infusion
Regulation Number	880.5725
Product Code	FRN
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K200176	FREEDOM Integrated Syringe Infusion System	FRN
Device Description Summary 21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The Freedom60 Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunodobulins when used according to the FDA approved biologic labeling: Cutaguig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma"); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda9); Hizentra°, Immune Globulin Subcutaneous

{6}------------------------------------------------

(Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to drug product labeling.

The Freedom60 Infusion System with the Freedom60® Infusion Pump and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.

The Freedom60 Infusion System consists of the following devices:

Freedom60® Infusion Pump
Precision Flow Rate Tubing
High-Flo Subcutaneous Needle Sets
HigH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the

subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru® Immune Globulin Infusion (Human) 20% (manufactured by Takeda®): Hizentra®, lmmune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)

The Freedom60 Infusion System is indicated for use with the following

syringes:

· BD® 50 ml syringe

· Medline® 60 ml Syringe

· Hizentra® 50 ml Prefilled Syringe

Indications for Use Comparison

21 CFR 807.92(a)(5)

The following changes have been made to the indications for use in comparison to the predicate devices:

The Hizentra 50ml Prefilled Syringe and Medline 60 ml syringe have been added as compatible syringes.
Minor changes have been made to product nomenclature.

The changes do not constitute a new intentra 50 ml Prefilled Syringe contains the same drug product as previously indicated for use with the predicate Freedom Infusion System, and the Medline 60 ml syringe is intended for the same use as the previously indicated BD 50 ml syringe. No new drug products have been added to the indications for use. The device will continue to be used for subcutaneous or intravenous infusion of the same medicinal products as the predicate device.

Technological Comparison

21 CFR 807.92(a)(6)

The subject device has the same technological characteristics as the predicate device. There have been no significant changes to the Freedom60 Infusion Pump, Precision Flow Rate Tubing, High-Flo Subcutaneous Needle Sets, and Super26 Subcutaneous Needle Sets from the predicate submission. The only modification to the addition of a removable, optional adapter which is inserted into the Freedom60 Infusion Pump to enable compatibility with a pre-filled syringes have been verified as compatible with the system when used in the same manner as the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following testing was performed in support of the modified device:

Flow rate verification
Reliability/use life verification
Dose accuracy and fitment
Human factors validation (per IEC 62366-1 and "Applying Human Factors and Usability Engineering to Medical Devices" Guidance)

Additional justification was provided for previously submitted testing which is applicable to the subject device.

Clinical testing is not applicable for this submission.

All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process. Additional justification was proviously conducted testing which supports the modified device.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).