(29 days)
No
The document describes a digital orthopedic planning workstation that uses templates and guides for surgical planning, without mentioning any AI or ML capabilities.
No.
The device is described as an orthopedic workstation designed to help surgeons plan procedures and monitor patient progress; it does not directly treat or diagnose a disease/condition.
No
The device is designed for surgical planning and monitoring patient progress, not for diagnosing medical conditions. It uses pre-existing images to help plan procedures and does not generate new diagnostic information.
No
The device is described as an "add-on component to the IMPAX client" and consists of an "Impax Diagnostic Workstation and templates." This implies it is software running on a specific hardware platform (the Diagnostic Workstation), not purely software independent of dedicated hardware.
Based on the provided text, the Agfa IMPAX OT3000 Orthopedic workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that the device is an "Orthopedic workstation" designed to help orthopedic surgeons access and plan surgical procedures using images (specifically x-ray images). It focuses on surgical planning, implant selection and placement, and monitoring patient progress based on imaging.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is centered around the manipulation and interpretation of medical images.
Therefore, the Agfa IMPAX OT3000 falls under the category of medical imaging software or a surgical planning system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Agfa IMPAX OT3000 Orthopedic Workstation is designed as an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. Along with basic diagnostic display station functionality the software is intended to read in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the Agfa Impax OT3000 software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.
The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to the surgeon's desktop using digital images acquired through the PACS system. These images can be scaled to actual size with the IMPAX System templates that reflect surgical placement of the implant. These plans can also be shown to patients and used as an aid to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. The application consists of guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
Product codes
LLZ, HWT
Device Description
Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and and operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons surgiour ownershow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeons and specialists
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Koso751
APR 2 1 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted by: Agfa Corporation 10 South Academy St. Greenville, SC 29602-9048
1. Date Prepared February 21, 2005
2. Contact Person
Phil Cuscuna Phone: (519) 746-2900 FAX: (519) 746-3745 CELL: (519) 572-9339 Email: phil.cuscuna@agfa.com
3. Device Name and Classification
Trade Name: Classification Name:
Classification Panel: CFR Section:
Device Class: Device Code:
IMPAX® OT3000 Orthopedic Workstation PACs system. Template for Clinical Use Radiology 21 CFR § 892.2050 21 CFR 888.4800 Class II LLZ and HWT
4. Intended Use
The Agfa IMPAX OT3000 Orthopedic Workstation is designed as an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. Along with basic diagnostic display station functionality the software is intended to read in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the Agfa Impax OT3000 software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.
5. Substantial Equivalence
The IMPAX® OT3000 orthopedic component is substantially equivalent to the Siemens' EndoMap (FDA Clearance # K014113; Clearance Date: 06/14/2002).
The Diagnostic Workstation was previously submitted for FDA approval (K022292; Clearance Date: September 12, 2002) by Agfa Corporation and (K993532; Clearance Date: December 15, 1999) by Impax Technology. The workstation component is considered here in this submission for its
1
integration with the OT3000 orthopedic software.
6. Device Description
Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and and operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons surgiour ownershow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
7. Comparison of Technological Differences:
Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate device.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Phil Cuscuna Regulatory Affairs for the Americas AGFA Corp Healthcare 10 South Academy St. GREENVILLE SC 29602-9048
Re: K050751 Trade/Device Name: Impax OT3000 Orthopedic Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system -Regulatory Class: II Product Code: LLZ Dated: February 21, 2005 Received: March 23, 2005
Dear Mr. Cuscuna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your bottler. by (1) = substantially equivalent (for the indications for use stated in above and nave determinerarketed 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 May 20, 1770, the chance 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 do not require upproval of a provisions of the Act. The general controls provisions of the Act device, subject to the generalian, 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 (Premarket If your de roo is elective (to such additional controls. Existing major regulations affecting your Apploval), it they of sabject to out Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device bail be found in nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I toast be adermination that your device complies with other requirements of the Act or any I DA has made a acteriminations administered by other Federal agencies. You must comply with all the I cara suiteres and regulation, but not limited to registration and listing (21 CFR Part 807); labeling ACC S requirements, moduling practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
APR 2 1 2005
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the support of any of a lot and can interest of your device to a lev This letter will allow you to begin marketing your advice of your device of your device to a legally premarket notification. The FDA inding of substantial organities 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
s and If you desire specific advice for your device on our laboring roganition (
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | - | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general manufacturers four copying to the free number (800) 638-2041 or (301) 443-6597 or at its Internet address
056-2011-01-01-01-01-01-2019/01/11/2019-01-11 11:11:11
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOSO751
EXHIBIT 3. Indications for Use Statement
510(K) Number (if known) Impax OT3000 Orthopedic Workstation Device Name The Agfa IMPAX OT3000 Orthopedic workstation is designed to help Indications The Agra im. For of and specialists access images, plan surgical for Use orthopedie surgeons and ops and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic AS an add-on component to the ino images acquired through the PACS application provides digital planning to the Sun System templates that reflect system. These images can be aimest images helping the surgeon plan the actual prostnetto implant. These plans can also be shown to Surgical placement of the implant. They will undergo and to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. The application consiols of anides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting. Please do not write below This line - continue on another PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription > Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use
Davidh. Sypmm
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number