(57 days)
The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.
Remote controlled radiology table, collimator and spot film device
I'm sorry, but the provided text does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance as requested.
The document is a 510(k) summary for the APOLLO remote-controlled radiology table. It focuses on establishing substantial equivalence to a predicate device by comparing technical specifications and intended use.
Specifically, the document does NOT contain information on:
- Acceptance Criteria for performance: It lists specifications of the device but not criteria against which its performance was measured to demonstrate safety and effectiveness.
- A "study that proves the device meets the acceptance criteria": There is no description of a clinical trial, performance testing study, or any other formal study conducted to "prove" the device's performance against specific metrics.
- Sample size or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The document is primarily a comparison table of features between the APOLLO and its predicate device (Philips Omnidiagnost Eleva) to demonstrate substantial equivalence, a regulatory pathway that doesn't typically require extensive performance studies as might be seen for novel devices or AI solutions.
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Image /page/0/Picture/0 description: The image shows a logo for Villa Sistemi Medicali. The logo features a stylized letter 'V' above the company name. The text 'VILLA' is in a larger font size than 'SISTEMI MEDICALI', which is stacked below it.
MAR 2 5 2005
Koso190
Attachment 1 - 510 (k) SUMMARY
510(k) summary for APOLLO
Identification
| Applicant | Villa Sistemi Medicali S.p.A.Via delle Azalee 3,20090 BUCCINASCO - Milan- ItalyRegistration Number: 8021091 |
|---|---|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | + 39 02 48859233 |
| Designated Agentin the US | Veronica MeredithDel Medical Imaging11550 West King StreetFranklin ParkIllinois 60131Tel. 847-288-7000 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.Via delle Azalee 3,20090 BUCCINASCO - Milan - Italy |
Trade name: APOLLO
Common name: APOLLO R/F remote controlled table
Classification:
The equipment is classified as a class II device since it is composed of the following three components:
radiological table (CFR892.1980): class I
spot film device (CFR892.1670): class II
X-ray beam limiting device (CFR 892-1610): class II
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150190
Substantial equivalent device: the APOLLO is defined as Substantially Equivalent (SE) to the Philips Medical Systems OMNIDIAGNOST ELEVA, manufactured by Philips Medical Systems and cleared by FDA with K032046
The following table compares the APOLI.O and the predicate device
| APOLLO | Philips Omnidiagnost Eleva | |
|---|---|---|
| Intended use | Remote controlled radiologytable, collimator and spot filmdevice | Remote controlled radiologysystem inclusive of remotecontrolled table, collimator,spot film device, imageintensifier system |
| Working height (tabletop center tofloorplate) | 600 -1400 mm | 840 -1140 mm |
| Table tilt movement | -90° - +90° | -90° - +90° |
| Table tilt speed | 4.5 -6.5°/sec | Variable 2-4.5°/sec |
| Table top suspension | Two sides suspension | Single side (left or right) |
| Table top material | 2379x750 Plastic laminate orcarbon fiber | 2250 x 660 mm carbon fiber |
| Table top movement | Patient remain stationaryduring all scan movments | Patient remain stationaryduring all scan movments |
| Table top absorption | Plastic:<0.5mm AlCarbon fiber: <0.3 mm Al@ 100kV, HVL 2.7mm Al | <= 1.1 mm Al eq. |
| Shape | Curved for max patientcomfort and autocentering | Curved for max patientcomfort and autocentering |
| Max patient weight | 150 kg | 200kg |
| Skin to film distance | 65 mm | 105 mm |
| Lateral scan distance | -160 - +160 mm | -160 - +160 mm |
| Lateral scan speed | 30 mm/sec | Variable 10 - 50 mm/sec |
| Longitudinal scandistance | 1600 mm | 1550 mm |
| Longitudinal scanspeed | 30 - 200 mm/sec | Variable 20-120 mm/sec |
| Table columnangulation | -40° - +40° | -40° - +40° |
| Table columnangulation speed | 11.2 °/sec | Variable 4°-8°/sec |
| Source image distance | Continuous variable between1000 and 1500 mm | Continuous variable between1100 and 1500 mm |
| Tube rotation | Manual +/-180° with stops at | Manual -90° - +180° with |
| 0°:+/-40°:+/-50°;+/-90°; 180° | stops at 0°-40°-90° | |
| Image intensifier lift | 32 mm in 0.8 sec | 32 mm in 0.8 sec |
| Collimator | Square/rectangular.Iris optional | Square/rectangular and Iris |
| Compressor movement | Motorized and parkable | Motorized and parkable |
| Compressor pressure | Adjustable between 30 and150 N in steps of 5 N | Adjustable between 40 and160 N |
| Automatic spot filmdevice | ||
| Cassette size | From 13x18cm to 35x43 | From 20x20 to 35x43 |
| Sudivisions | 1, 2, 3, 4 in line4, 6 in cross | 1, 2, 3. 4 in line4, 6 in cross |
| Load unload time | 2 sec | 2 sec |
| Preparation time forexposure | 0.8 sec (min) | 1.2 sec |
| Rapid sequence | yes | 6 exposure in 4 sec |
| Grid | parkable | parkable |
| Tomography | ||
| Movement | Arc- plan motion: at 45°, 30°,20°, 7° | Linear at 40°, 20° or 8° |
| Layer height range | 0 - 300 mm with automaticlayer height increments | 10 - 250 with automatic layerheight increments |
| Sweep time | 2 sec:4 0 or 2.5 sec at 45°2.7 or 1.3 sec at 30°1.8 or 0.9 sec at 20°0.6 Or 0.3 sec at 7° | 2 speeds:3 0 or 1.5 sec at 40°1.5 or 0.75 sec at 20°0.6 or 0.3 sec at 8° |
510(K) Summary for APOLLO
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Indication for use.
The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it, on the right side. On the left side, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2005
Villa Sistemi Medicali S.p.A. % Ms. Veronica Meridith Official Correspondent Del Medical Imaging 11550 West King Street FRANKLIN PARK IL 60131 Re: K050190
Trade/Device Name: APOLLO Regulation Number: 21 CFR 892.1980 Regulation Name: Radiologic table Regulation Number: 21 CFR 892.1670 Regulation Name: Spot-film device Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: KXJ, IXL, and KPW Dated: January 25, 2005 Received: February 10, 2005
Dear Ms. Meridith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 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 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) rms tetter wrification. The FDA finding of 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 n Joan t 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 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for use Statement 5.1.
510(k) Number:
Device Name: APOLLO
The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.
Prescription Use
Nancy C. Broodon
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ivision Sign-Off ivision of Reproduc d Radiological Devi
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.