COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

K012832 · Nxstage Medical, Inc. · LGZ · Oct 24, 2001 · General Hospital

Device Facts

• Record ID: K012832
• Device Name: COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
• Applicant: Nxstage Medical, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Oct 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ComfortMate™ Fluid Warming System is intended to be used for the warming of fluids prior to administration.

Device Story

ComfortMate Fluid Warming System warms fluids to 30°C–37°C at flow rates up to 200 ml/min; consists of reusable warming unit and single-use disposable. User inserts disposable into unit; door closure engages disposable with heater plates; fluid warms while flowing through disposable. Front panel knob allows selection of 9 temperature settings. Used by healthcare professionals in clinical settings. Output is warmed fluid for patient administration; helps maintain patient normothermia. Device does not warm blood or blood products.

Clinical Evidence

Bench testing only. Design verification testing performed to confirm system functions as intended.

Technological Characteristics

System comprises reusable warming unit and single-use disposable. Heating via heater plates. Temperature control via front panel knob with 9 settings. Operating range 30°C to 37°C. Flow rate up to 200 ml/min.

Indications for Use

Indicated for warming fluids prior to administration. Not validated for blood or blood products.

Regulatory Classification

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.

Predicate Devices

• Bair Hugger® Blood/Fluid Warmer (K973741)
• MaxOne IV Fluid/Blood Warmer (K002409)
• Medi-Temp II FW300 Blood/Fluid Warmer (K950038)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an abstract caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

## JAN 1 0 2017

Ms. Karen St. Onge Director, Quality Assurance/Regulatory Affairs NxStage Medical, Incorporated 439 South Union Street, 5th Floor Lawrence, Massachusetts 01843

Re: K012832

Trade/Device Name: ComfortMate Fluid™ Warming System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: August 22, 2001 Received: August 23, 2001

Dear Ms. St. Onge:

This letter corrects our substantially equivalent letter of October 24, 2001.

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.

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 Parts 801 and 809 ); medical device reporting (reporting of

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Page 2 - Ms. Karen St. Onge

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 Parts 801 and 8091 ), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012832

Image /page/2/Picture/1 description: The image shows the text "NxSTAGE" in a stylized font. The "Nx" is in a bold, cursive style, while "STAGE" is in a more blocky, distressed font. The overall impression is of a logo or brand name.

439 South Union Stree Lawrence. v: 978.687.4700 978.687.4800

## Indications for Use Statement

Device Name:

ComfortMate™ Warming System

Indications for Use:

The ComfortMate™ Fluid Warming System is intended to be used for the warming of fluids prior to administration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ ﻟﻤﺴﻠﻤﺎ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

## Patricia Cusack

!Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 4.1 [i(k) Number _

032

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## OCT 2 4 2001

#### NxStage Medical, Inc. ComfortMate™ Fluid Warming System 510(k) Premarket Notification

4012832

## Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

#### A. Submitter's Information:

| Name: | NxStage Medical, Inc. |
|----------------------|-------------------------------------------------------------------|
| Address: | 439 South Union Street, 5th Floor<br>Lawrence, MA 01843 |
| Phone: | 1-978-687-4700 |
| Fax: | [phone] |
| Contact Person: | Karen St. Onge,<br>Director, Quality Assurance/Regulatory Affairs |
| Date of Preparation: | 22 August 2001 |

#### B. Device Name:

| Trade Name: | ComfortMate™ Fluid Warming System |
|----------------------|-----------------------------------|
| Common/Usual Name: | Warmer, Thermal, Infusion Fluid |
| Classification Name: | Warmer, Thermal, Infusion Fluid |

#### C. Predicate Device Name:

The predicate devices for the ComfortMate™ Fluid Warming System are the following:

#### Warmer:

- Bair Hugger® Blood/Fluid Warmer #K973741 (4/30/98): ●
- MaxOne IV Fluid/Blood Warmer #K002409 (6/28/01); ●
- Medi-Temp II FW300 Blood/Fluid Warmer Originally 510(k)-cleared as the . Dupaco CounterFlo 300 Blood/Fluid Warmer System - #K950038.

#### Warmer Disposable:

- Bair Hugger® Blood/Fluid Warmer #K973741 (4/30/98); . Medi-Temp II FW300 Blood/Fluid Warmer - Originally 510(k)-cleared as the Dupaco CounterFlo 300 Blood/Fluid Warmer System - #K950038.

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## NxStage Medical, Inc. ComfortMate™ Fluid Warming System 510(k) Premarket Notification

## Summary of Safety and Effectiveness

#### D. Device Description/Indications for Use:

The ComfortMate™ Fluid Warming System is designed to warm fluids to 30℃ to 37℃ prior to patient administration, at flow rates of up to 200 ml/min. The ComfortMate™ consists of a reusable fluid warming unit and a single-use warmer disposable. To use the ComfortMate™, the warmer disposable is inserted into the warming unit. Once the warming unit's door is closed, the warmer disposable comes into contact with the warming unit heater plates. Fluids are warmed as they flow through the disposable. The knob on the front panel allows the user to choose from 9 temperature comfort settings. The ComfortMate™ has not been validated for the warming of blood or blood products.

#### Intended Use

The ComfortMate™ Fluid Warming System is intended to be used for the warming of fluids prior to administration.

#### E. Substantial Equivalence:

#### 510(k) Substantial Equivalence Decision Making Process

#### 1. Is the product a device?

YES - The components of the ComfortMate™ Fluid Warming System are devices pursuant to 21 CFR §201 [321] (h).

#### 2. Does the new device have the same intended use?

YES - The intended use for the ComfortMate™ Fluid Warming System is equivalent to those for the predicate warming systems.

#### ComfortMate™ Fluid Warming System

The ComfortMate™ Fluid Warming System is intended to be used for the warming of fluids prior to administration.

#### Bair Hugger Ranger Blood/Fluid Warmer (#K973741)

The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products and liquids.

#### MaxOne™ IV Fluid/Blood Warmer (#K002409)

The MaxOne™ IV Fluid/Blood Warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.

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## NxStage Medical, Inc. ComfortMate™ Fluid Warming System 510(k) Premarket Notification

## Summary of Safety and Effectiveness

#### Medi-Temp II Blood/Fluid Warmer (#K950038)

This device is intended to aid in the prevention of hypothermia during administration of blood, blood products, and other fluids.

#### 3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?

NO - The functional characteristics of the ComfortMate™ Fluid Warming System are equivalent to those of commercially available warming systems and raise no new types of safety or effectiveness questions. In addition, the results of design verification testing indicate that the ComfortMate™ Warming Unit and Disposable function as intended.

#### 4. Does descriptive or performance information demonstrate equivalence?

YES - NxStage Medical, Inc. believes that the information provided in this submission clearly describes the ComfortMate™ Fluid Warming System and demonstrates that it is substantially equivalent to other commercially available warmers.

#### F. Safety Summary

The ComfortMate™ verification testing rigorously tested the features of the ComfortMate™ system. The results of this testing indicate that the ComfortMate™ system is safe and effective for its intended use.

#### G. General Safety and Effectiveness Concerns

The device labeling contains an Operator's Manual, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the ComfortMate™ Fluid Warming System. This information promotes safe and effective use of the device.

Karen St Onge

Karen St. Onge Director, Quality Assurance/Regulatory Affairs

8/22/01
Date