← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K090044

# PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C (K090044)

_Oncolog Medical QA AB · IYE · Jan 22, 2009 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K090044

## Device Facts

- **Applicant:** Oncolog Medical QA AB
- **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md)
- **Decision Date:** Jan 22, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## Indications for Use

System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit. Intended User: The PatLog Patient Handling System is intended to be used by qualified radiotherapy personnel trained in using the device.

## Device Story

PatLog 1.0 is a patient handling system comprising a patient table plate, docking unit, and transport trolley. It facilitates patient setup, transport between diagnostic devices and treatment rooms, and positioning/fixation on a treatment couch. Operated by qualified radiotherapy personnel in clinical settings. The system allows the patient table plate to be docked at treatment or diagnostic units and undocked for transport via the trolley. It supports patient stability during radiotherapy workflows. No automated diagnostic or therapeutic algorithms are described; the device functions as a mechanical patient support and transport platform.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Mechanical patient handling system consisting of a patient table plate, docking unit, and transport trolley. Designed for patient positioning and fixation on treatment couches. No electronic or software-based control systems described for the PatLog 1.0 itself; mechanical docking and transport mechanism.

## Regulatory Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

## Predicate Devices

- Hercules Radiation Therapy Couch and ATLAS Couch Top ([K950061](/device/K950061.md))
- Intera 1.5 T MRI ([K030520](/device/K030520.md))

## Submission Summary (Full Text)

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>
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ંગ્રિક્ષુર્ડ

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178

ONCOlog Medical QA AB Vallvägen 4B SF-756 51 Uppsala Sweden TEL. +46 (0)18-19 45 65 FAX +46 (0)18-30 06 85 www.oncologmedical.com

> Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMA-TION

### as required by section 807.92(c)

#### Submitter of 510(k):

Company name: Registration number: Address:

Phone: Fax: Correspondent: ONCOlog Medical QA AB 10026961 Vallvägen 4B 756 51 Uppsala Sweden (011) 4618194565 (011) 4618300685 Hans Dahlin and Jan Törnqvist

#### New Device Name:

| Trade/Proprietary Name: | PatLog 1.0.                                       |
|-------------------------|---------------------------------------------------|
| Common/Usual Name:      | Radiotherapy Patient Handling System              |
| Classification Name:    | Medical charged-particle radiation therapy system |
| Classification:         | 21 CFR 892.5050, Product Code IYE Class II        |

#### Legally Marketed Device(s)

Our new device is based on the legally marketed device cited in the table below:

| Manufacturer                                            | Device                                                  | 510(k) # |
|---------------------------------------------------------|---------------------------------------------------------|----------|
| Precision Therapy International/<br>Precitron AB Sweden | Hercules Radiation Therapy Couch and<br>ATLAS Couch Top | K950061  |
| Philips Medical Systems North Amer-<br>ica Co           | Intera 1.5 T MRI                                        | K030520  |

JAN 22 2009

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ONCOlog Medical QA AB

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### 14.1. Device description

The PatLog 1 0 Pattent Handling System is a combination of separate components that facılıtates setup of the patient on a Patıent Table Plate, transport to diagnostic devices, and/or to the treatment room and back after the treatment The Pattent Table Plate 1s docked on the patient table bases at each unt and undocked for the transport between stations with the Transport Trolley

The system consists of the following components

- � Patient table plate
- . Docking unit
- . Transport trolley

### 14.2. Intended use

System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit

Intended User The PatLog Pattent Handling System is intended to be used by qualified radiotherapy personnel trained in using the device

# 14.3. Technological characteristics of the Predicate Devices

The Philips Intera MRI have a table top suitable for MR examinations - as the PatLog table top

The Hercules Radiation Therapy Couch is an electrically powered adjustable couch intended to support patients during radiation therapy The Hercules main frame consists of a T-shaped base with two vertical lifting columns The frame rests on three wheel pars, one in each comer Each wheel par consists of two driving wheels with one motor each The wheel pairs can turn freely around a vertical axis between the wheels

The Atlas couch top consists of a base section that is bolted to the consols at the lifting columns, and a top section connected to the base section with two C-arms that can be turned 270 degrees The C-arms provide a 650 mm long free opening for irradiation from any angle and have brakes for locking in the selected position

The ends of the couch have rollers for the polyester belt that supports the patient across the free ovening The roller at the base section is fixed and contains the belt drive motor The roller at the top section adjusts the tension of the belt

There are 8 automatic, 1 e computer controlled modes for Hercules The lift and the Atlas belt motions do not require computer assistance for proper function

The Hercules couch has a backup system that permits local control of the couch without use of the computer A separate battery charger transformer isolates the couch from the mans supply and provides ±18V DC to the regulators in the couch for charging the batteries The couch is powered by four 12V lead-acid batteries

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## 14.4. Summary of Technological Characteristics and Intended Use

The technological characteristics and the intended use are substantially the same for Pat-Log Pattent Handling system as for Hercules Radiation Therapy Couch and ATLAS Couch Top

Name Hans Dahlın Title CEO ONCOlog Medical QA AB Uppsala, Sweden

Date

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

: ****

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 2 2009

ONCOlog Medical QA AB % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc 1285 Walt Whitman Rd MELVILLE NY 11747

ಳ್ಳಿ

Re K090044

Trade/Device Name PatLog 1 0 Regulation Number 21 CFR 892 5050 Regulation Name Medical charged-particle radiation therapy system Regulatory Class II Product Code IYE Dated December 31, 2008 Received January 7, 2009

### Dear Mr Conry

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 regustration, 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 (PMA), it may be subject to such 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 conceming your device in the Federal Register

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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; 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

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter

| 21 CFR 876 xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|----------------|----------------------------------|----------------|
| 21 CFR 884 xxx | (Obstetrics/Gynecology)          | (240) 276-0115 |
| 21 CFR 892 xxx | (Radiology)                      | (240) 276-0120 |
| Other          |                                  | (240) 276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket nottfication" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html

Sincerely yours,

Janine M. Morris

anine M. N Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number

Device Name

Indications for Use

K090044

PatLog 1 0

System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit

Intended User

The PatLog Patient Handling System is intended to be used by qualified radiotherapy personnel trained in using the device

Prescription Use _ X (Part 21 CFR 801 subpart D) AND/OR Over-The-Counter Use_

(Part 21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tom May
(Division Sign-Off)

· vision of Reproductive, Abdominal a Radiological Devices

10(k) Number K09004

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