(58 days)
The Inclined Platform-Lift "JOURNEY" is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either in indoors or outdoors.
The JOURNEY consists of a motorized main-frame with a platform, moving on a public of The JOURNET Consists of a motorized man interest man and on the discussion fixed floors in a public of piritor of a fack placed at the bottom of the blood garror, it The JOURNEY is designed to carry a private dwelling; it is an unenclosed Inclined Platformlift. The JOURNEY of wheelchair and its occupant or a person with impaired mobility seated on a folding seat. There are currently two different models designed to address different kind of staircase. - The JOURNEY (technically called RPSP) designed strictly for straight stairways. ■ - The JOURNEY (technically called TP or ) docigned for straight and turning stairways. Starways. Each of the two models is accessible via four types of platform (special size are available under Each of the two models is accessible via four types of plations (promps are raided automatically (manually in emergency cases). (fridaliy in emergency casos). The JOURNEY, as rail, uses one guide, dimensions roughly 400 mm x 65 mm, the guide is made in extruded aluminium profile (TK Ceteco drawing) and anodised. The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according to the stainway. The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according T The JOUNCT GODIO, as Tail, acco two paralier garabel on extruded aluminium profile (TK Ceteco drawing) and powder coated painted. The guide follows the average of staircase and is supported by specific stanchions, anchors on the steps and/or to the wall. steps and/or to the wall. The JOURNEY is equipped with an "Over-speed Governor and Safety Gear" that it is directly and THE JOURNET is equipped with an "Over operated directly by a speed limiter device with mechanically liked on the 'system of the traction system, the insettion system, the insertion of the mput menta due to the merceased specu, in caso of failers of the armanical arrest" of the platform lift. the JOURNEY is equipped with "Hold to run Buttons" and with an emergency stop button. The JOURNEY is also provided the following safety devices: - onNice is also provided the following eactly in motion towards' high on both the body and the platform; 포 - anti-scissor system in motion down under the bottom of the platform and on the bottom of the . bodv: - body, I
The provided text describes a 510(k) premarket notification for a medical device, which typically focuses on establishing substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel, high-risk device might.
The document does not contain the information requested in points 1-9 regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a clinical or performance study of the "JOURNEY" Inclined Platform-Lift.
Instead, the document is a regulatory communication from the FDA stating that the device is "substantially equivalent" to a legally marketed predicate device (K981486). This determination is based on the device conforming to general controls and having similar indications for use and technological characteristics to the predicate device. For devices like this, the "study" is often an engineering and safety assessment against recognized standards for inclined platform lifts, demonstrating that it meets safety requirements and performs its intended function comparably to existing, approved devices.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The submission focuses on regulatory clearance, not on presenting performance data from a specific study with defined acceptance criteria.
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510 (K) SUMMARY
(In accordance with 21 CFR 807.92)
Submitted by:
ThyssenKrupp Ceteco S.r.l. Via S. Cannizzaro nº 2 56121 PISA (PI) - ITALY
MAY 2 7 2009
1
Contact: Fabrizio Fedele or (Fabio Sbrana, Fabio Neri) E-mail: f.fedele@ceteco.it or (f.sbrana@ceteco.it, f.neri@ceteco.it ) Tel. 0039 050 955111 Fax 0039 050 982255
23 March 2009 Date prepared:
JOURNEY Trade Name:
Common Device Name: Wheelchair Elevator or Inclined Platform Lift
Garaventa Stairlilft GSL Inclined Platform Lift Predicate device: K981486 21CFR 890.3930 Classification code: ING
Product description:
Product description.
The JOURNEY consists of a motorized main-frame with a platform, moving on a public of The JOURNET Consists of a motorized man interest man and on the discussion fixed floors in a public of piritor of a fack placed at the bottom of the blood garror, it The JOURNEY is designed to carry a
private dwelling; it is an unenclosed Inclined Platformlift. The JOURNEY of wheelchair and its occupant or a person with impaired mobility seated on a folding seat.
There are currently two different models designed to address different kind of staircase.
- The JOURNEY (technically called RPSP) designed strictly for straight stairways. ■
- The JOURNEY (technically called TP or ) docigned for straight and turning stairways.
Starways.
Each of the two models is accessible via four types of platform (special size are available under Each of the two models is accessible via four types of plations (promps are raided automatically (manually in emergency cases).
(fridaliy in emergency casos).
The JOURNEY, as rail, uses one guide, dimensions roughly 400 mm x 65 mm, the guide is made in extruded aluminium profile (TK Ceteco drawing) and anodised.
The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according to the stainway.
The JOURNEY CUBIC, as rail, uses two parallel guides, custom-bended according T The JOUNCT GODIO, as Tail, acco two paralier garabel on extruded aluminium profile (TK Ceteco drawing) and powder coated painted.
The guide follows the average of staircase and is supported by specific stanchions, anchors on the steps and/or to the wall.
steps and/or to the wall.
The JOURNEY is equipped with an "Over-speed Governor and Safety Gear" that it is directly and THE JOURNET is equipped with an "Over operated directly by a speed limiter device with mechanically liked on the 'system of the traction system, the insettion system, the insertion of the mput menta due to the merceased specu, in caso of failers of the armanical arrest" of
the platform lift.
the JOURNEY is equipped with "Hold to run Buttons" and with an emergency stop button. The JOURNEY is also provided the following safety devices:
- onNice is also provided the following eactly in motion towards' high on both the body and the platform; 포
- anti-scissor system in motion down under the bottom of the platform and on the bottom of the . bodv:
- body, I
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard
Public Health Service
Rockville MD 20850
Tyssenkrupp Ceteco Srl % Mr. Fabrizio Fedele Via, S. Cannizzaro, 2 Pisa Italy 56121
Re: K090856
Trade/Device Name: Inclined Platform-Lift "Journey" Regulation Number: 21 CFR 890.3930 Regulation Names: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: April 28, 2009 Received: May 7, 2009
Dear Mr. Fedel:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Fabrizio Fedele
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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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Statement of Indications for Use
510(k) Number (if known):
Device Name:
Inclined Platform-Lift "JOURNEY"
Indications for Use:
The Inclined Platform-Lift "JOURNEY" is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either in indoors or outdoors.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
signature
(Dision Sign-Off) (Division Sign-Oil), Orthopedic, Orthopedic,
Division of Surgical, Orthopedic, Division of Surfaces and Restorative Devices
510(k) Number -
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.