Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management.
Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump.
Freedom™is a single use only device.
Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment.
Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery.
Freedom™is not intended for use with chemotherapy drugs.
Freedom™is not intended for use with blood, blood products, or TPN.

Device Description

The Freedom™ Infusion System pump will conform to the AMMI Draft Infusion Device Standard. The intended use of the Freedom™ Infusion System is identical to the legally marketed PainBuster system.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Freedom™ Infusion System. It indicates that the device is substantially equivalent to a legally marketed predicate device (PainBuster system). However, the document does not contain the detailed information requested to describe specific acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML powered device.

The document discusses:

Standards and Intended Use: The device will conform to the AAMI Draft Infusion Device Standard, and its intended use is identical to the legally marketed PainBuster system.
Manufacturing and Testing Procedures: Mentions Class 10,000 clean room manufacturing, 100% testing of silicone balloons to 110±5 mmHg (clinical operating pressure ~70 mmHg), and traceability.
Prior In-Vitro Tests and Clinical Experience: References FDA file numbers (K930404, K941766, K955849) for burst testing, flow rate, flow profile, and accuracy bench tests. It also mentions clinical experience with DIB pumps for obstetrical analgesia, post-operative pain, chronic pain, and intravenous infusions in the USA.

Therefore, based on the provided text, I cannot complete the requested table and answer the specific numbered questions concerning acceptance criteria and a study proving the device meets those criteria, as the document does not contain the necessary information.

Here's why and what's missing:

Acceptance Criteria Table: The document states conformity to an AAMI Draft Infusion Device Standard and internal pressure testing for balloons. However, it does not quantify specific performance metrics as acceptance criteria (e.g., accuracy +/- X%, error rate < Y%). It just states "100% tested to an internal pressure of 110±5 mmhg."
Study Details (for AI/ML powered device): The document describes a traditional medical device (infusion pump) and its prior testing. It does not mention any AI/ML component or studies related to AI/ML performance. Consequently, all questions related to sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and cannot be answered from this document.
Ground Truth: The "ground truth" here would relate to the physical performance of the pump (e.g., actual flow rate, burst pressure) rather than expert consensus on medical images or patient outcomes as implied by the questions. The document only states "bench test protocols and study results for flow rate, flow profile, and accuracy are also reported in the above referenced FDA filings."

In summary, the provided text describes the regulatory clearance for a physical medical device (an infusion pump) and its manufacturing/testing in the context of substantial equivalence to a predicate device, not an AI/ML powered device or the detailed performance study of such a device.

Summary

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SEP 1 0 1999

K992015

ATTACHMENT G

SUMMARY of SAFETY and EFFECTIVENESS for the DIB-RA INFUSOR

I. Standards and Intended Use

The Freedom™ Infusion System pump will conform to the AMMI Draft Infusion Device Standard. The intended use of the Freedom™ Infusion System is identical to the legally marketed PainBuster system.

II. Manufacturing and Testing Procedures

All manufacturing operations are performed in a class 10,000 clean room in accordance with GMP regulations. The silicone balloons are 100% tested to an internal pressure of 110+5 mmhg. Normal clinical operating pressure has been measured at approximately 70 mmhg. Full traceability of production lots will be maintained.

Prior In-Vitro Tests and Clinical Experience III.

A) Performance data and test protocols for burst testing of the DIB infusors are included as FDA file no's. K930404, K941766, and K955849. Bench test protocols and study results for flow rate, flow profile, and accuracy are also reported in the above referenced FDA filings

B) Clinical Experience: legally marketed DIB pumps have been used clinically in the USA for obstetrical analgesia, post operative pain, chronic pain and intravenous infusions. (See attached Anesthesiology News)

Contact Address: Inquiries related to the Freedom™ Infusion System should be IV. directed to:
NOVACON Corporation 5451 Hilltop Avenue Lake Elmo. MN 55042-9539 Tel: (651) 704-9160 Fax: (651) 704-9161

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

Mr. David P. Lanq NOVACON Corporation 5451 Hilltop Avenue North Lake Elmo, Minnesota 55042-9539

K992015 Re: Freedom™ Infusion System Trade Name: Regulatory Class: II Product Code: MEB Dated: June 11, 1999 Received: June 15, 1999

Dear Mr. Lang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Lang

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Citrus

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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사용량 및

: 上海:

	ATTACHMENT A
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F=============================================================================================================================================================================

510(k) Number (if known): Freedom™ Infusion System Device Name: –

Indications For Use:

1. Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management.
1. Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump.
1. Freedom™is a single use only device.
1. Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment.
1. Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery.
1. Freedom™is not intended for use with chemotherapy drugs.
1. Freedom™is not intended for use with blood, blood products, or TPN.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K992015

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
		(Optional Format 1-2-96)

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).