(89 days)
No
The description focuses on mechanical and hydrotherapy features, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is described as relieving pain and itching and aiding in the healing process of inflamed and traumatized tissue, which are therapeutic effects.
No
The "Intended Use" description focuses on relieving pain, itching, aiding healing, and removing contaminated tissue, which are therapeutic and palliative actions, not diagnostic ones. There is no mention of identifying, detecting, or monitoring a disease or condition.
No
The device description clearly states it is a "bathing system consists of a tub composed of fiberglass, which is covered by a panel containing all the integrated technical controls of the system," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes relieving pain and itching, aiding healing of tissue, and removing contaminated tissue. These are all therapeutic actions performed on the patient's body.
- Device Description: The device is a bathing system with a tub, controls, and optional features like hydro massage and disinfection. This is a physical device used for bathing and therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device operates in vivo (on the body) for therapeutic and hygienic purposes.
N/A
Intended Use / 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.
Product codes
ILJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964926, K930665, K001079, K930624
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5100 Immersion hydrobath.
(a)
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.(b)
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.
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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 : +46-413-64500 Fax . : +46-413-13876 Establishment Registration: 9611530
1.2 Address of 510(k) Holder Facilities
ArjoHuntleigh, Inc. 2349 West Lake Street, Suite 250 Addison, IL 60101 USA Phone: + (630) 785-4885 Fax: +(630) 576-5012 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: 630.576.5012 Brenda.Ammonette@ArjoHuntleigh.com
Arjo Hospital Equipment AB
Verkstadsvägen 5
PO Box 61
SE-241 21 Eslöv, Sweden
Phone: +46 (0) 413 645 00
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
Image /page/0/Picture/12 description: The image contains a logo with text. The text on the left side of the image says "ABS MARINE AMERICAN BUREAU Certification". On the right side of the image is a circular logo with a figure in the center. The text around the figure says "ABS QUALITY EVALUATIONS, INC."
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 (800) 638-2041 or (301) 796-7100 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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