PARKER 500

K110994 · Arjohuntleigh, Inc. · ILJ · Jul 6, 2011 · Physical Medicine

Device Facts

• Record ID: K110994
• Device Name: PARKER 500
• Applicant: Arjohuntleigh, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Jul 6, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue

Device Story

Parker 500 Immersion Hydrobath is a non-sterile bathing system used in clinical settings for patient hygiene and therapeutic care. The system consists of a fiberglass tub with an integrated control panel. Optional features include a tub height positioning system, tub tilt system, hydro-massage, and an integrated disinfection system. The device is operated by healthcare personnel to provide a controlled environment for hydrotherapy. By immersing the patient, the device facilitates pain relief, itching reduction, and the cleaning of inflamed, traumatized, or contaminated tissue, supporting the healing process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and functional comparison to predicate devices.

Technological Characteristics

Fiberglass tub construction; integrated control panel; optional height positioning, tilt, hydro-massage, and disinfection systems. Non-sterile device. Operates as an immersion hydrobath for physical medicine applications.

Indications for Use

Indicated for patients requiring relief from pain and itching, aid in healing of inflamed or traumatized tissue, and removal of contaminated tissue.

Regulatory Classification

Identification

An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Parker 420 (K964926)
• Century / Saflift (K930665)
• Rhapsody (K001079)
• Whirlpool bathing system (K930624)

Submission Summary (Full Text)

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# JUL - 6 2011

#### CHAPTER 5

# ARJOHUNTLEIGH

### 510(k) Summary

#### 1.1 Address of Manufacturing Facilities

Arjo Hospital Equipment AB Verstadsvägen 5 S-241 21 Eslöv Sweden Phone : [phone] Fax . : [phone] Establishment Registration: 9611530

#### 1.2 Address of 510(k) Holder Facilities

ArjoHuntleigh, Inc. 2349 West Lake Street, Suite 250 Addison, IL 60101 USA Phone: + [phone] Fax: +[phone] Establishment Registration: 1419652

#### 1.2.1 Official Correspondent

Arjo Huntleigh, Inc. 2349 West Lake Street, Suite 250 Addison, IL 60101 USA Establishment Registration: 1419652 Brenda Ammonette Sr. Director of Regulatory Ph: 630.785.4885 800.323.1245, ext. 54885 Fax: [phone] [e-mail]

Arjo Hospital Equipment AB
Verkstadsvägen 5
PO Box 61
SE-241 21 Eslöv, Sweden
Phone: [phone]
Fax: +46 [0] 413 138 76

Nordea Bank Sweden AB
IBAN SE64 3000 0000 0303 0780 0954
Bankgiro 191-6733
Org nr 556247-0145, F-skattebevis
VAT no.: SE556247014501
www.arjohuntleigh.com

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Image /page/0/Picture/13 description: The image shows a black and white circular logo. Inside the circle is a heart shape with a downward-pointing triangle inside it. The heart and triangle are white, and the rest of the logo is black. There is some text around the edge of the circle, but it is too blurry to read.

MEMBER OF THE GETINGE GROUP

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#### CHAPTER 5

# ARIOHUNTLEIGH

#### 1.3 Device Classification

Device name: Device class: Classification Panel: Classification Number: Product Code: Trade/Proprietary Name:

Parker Immersion Hydrobath 11 Physical Medicine 890.5100 ILJ Arjo or Arjo Huntliegh followed by Parker 500

#### 1.4 Substantially Equivalent to

Parker 500 is substantially equivalent to the following predicate devices:

- Parker 420 (the manufacturer's predecessor device cleared under . K964926).
- Century / Saflift (Arjo-Century Inc, cleared under K930665) .
- Rhapsody (Arjo Inc, cleared under K001079) .
- Whirlpool bathing system (DUTTON-LAINSON CO, cleared under ● K930624)

#### 1.5 Description of the Device

The bathing system consists of a tub composed of fiberglass, which is covered by a panel containing all the integrated technical controls of the system. The bathing system is offered with or without a tub height positioning system, tub tilt system, hydro massage and an integrated disinfection system. The bathing system is not a sterile device.

#### Indications for use

To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

#### 1.7 Summary of Comparison Data

Parker 500 uses the same fundamental technology features and safety functionalities as the Parker Bath Systems (K964926), Century/Safiift Whirlpool bathing system (K930624) and (K930665). Rhapsody (K001079). Therefore, it is concluded that there is no significant difference in the basic function, safety and efficacy between the Parker 500 and the predicate devices.

### 1.8 Date Summary Prepared

Monday the 7th of March 2011

Berndx Ammatti

Brenda Ammonette Sr. Director of Regulatory ArjoHuntleigh, Inc., USA

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

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

JUL - 6 2011

ArjoHuntleigh, Inc. % Ms. Brenda Ammonette Senior Director of Regulatory 2349 West Lake Street, Suite 250 Addison, Illinois 60101

Re: K110994

Trade/Device Name: Parker 500 Immersion Hydrobath Regulation Number: 21 CFR 890.5100 Regulation Name: Immersion hydrobath Regulatory Class: Class II Product Code: ILJ Dated: April 08, 2011 Received: April 08, 2011

Dear Ms. Ammonette:

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

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Page 2 - Ms. Brenda Ammonette

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ed Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Not known

#### Device Name: Immersion hydrobath

Indications for Use:

- To relieve pain and itching and as an aid in the healing process of inflamed and . traumatized tissue, and it serves as a setting for removal of contaminated tissue
Prescription Use (Part 21 CFR 801 Subpart D)

:

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110994

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