(75 days)
Not Found
No
The device description relies on simple pneumatic and ballistic principles, and there is no mention of AI or ML in the provided text.
No
The device is used for the physical removal of bone cement during surgery, which is a mechanical intervention rather than a device designed to treat or cure a disease or condition through non-physical means.
No
The device is used for the removal of bone cement during implant revision surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels, hollow drill, extractor, and Orthoscope.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal of bone cement during implant revision surgery." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device description details a system that physically fragments bone cement using pneumatic and ballistic principles. This is a mechanical action, not a diagnostic test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The Swiss OrthoClast® does not perform any such tests.
The Swiss OrthoClast® is a surgical tool used for a specific procedure, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery.
Product codes
HSZ, LZV, GET
Device Description
The EMS Swiss OrthoClast® system consists of a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels of various sizes and shapes, a hollow drill and extractor for removal of the cement tip, and the Orthoscope. The Swiss OrthoClast® uses simple pneumatic and ballistic principles to fragment bone cement. A pressure pulse generated by the pressure regulator/control unit causes a moveable projectile in the handpiece to be driven forward to strike the proximal end of the chisel. The impact generates a shock wave along the chisel, which leads to a small, high-speed excursion of the chisel tip. The distal end of the chisel is held in contact with the targeted cement. Repetitive shock waves result in fragmentation of the bone cement. A short tip excursion period followed by a longer rest period prevents the build-up of heat in the fragmentation site. Direct vision into body cavities, such as the femoral cavity, is facilitated using the Orthoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comprehensive risk analysis was conducted to identify potential hazards associated with the use and misuse of the Swiss OrthoClast®. Verification tests conducted as a result of this risk analysis include the following
- Maximum excursion and velocity of the Swiss OrthoClast® chisel tips ●
- Handpiece and chisel longevity
- In vitro cement fragmentation efficiency .
- Orthoscope temperature elevation
The results of these tests confirmed that the Swiss OrthoClast® met the design objectives as identified by the risk analysis.
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
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
91588
510(k) Summary . for Swiss OrthoClast®
1. SPONSOR
EMS SA Ch. de la Vuarpillière 31 CH-1260 Nyon Switzerland
| Contact Person: | Gianni Campana |
|---|---|
| Telephone: | 011 41 22 9944770 |
May 5, 1999 Date Prepared:
2. DEVICE NAME
Swiss OrthoClast® Proprietary Name: Powered orthopedic surgical instrument Common/Usual Name: Instrument, surgical, orthopedic, pneumatic powered and Classification Name: accessories
3. PREDICATE DEVICE
Ceboplane® (K933933)
4. INTENDED USE
The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery.
5. DEVICE DESCRIPTION
The EMS Swiss OrthoClast® system consists of a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels of various sizes and shapes, a hollow drill and extractor for removal of the cement tip, and the Orthoscope. The Swiss OrthoClast® uses simple pneumatic and ballistic principles to fragment bone cement. A pressure pulse generated by the pressure regulator/control unit causes a moveable projectile in the handpiece to be driven forward to strike the proximal end of the chisel. The impact generates a shock wave along the chisel, which leads to a small, high-speed excursion of the chisel tip. The distal end of the chisel is
1
held in contact with the targeted cement. Repetitive shock waves result in fragmentation of the bone cement. A short tip excursion period followed by a longer rest period prevents the build-up of heat in the fragmentation site. Direct vision into body cavities, such as the femoral cavity, is facilitated using the Orthoscope.
6. PERFORMANCE TESTING
A comprehensive risk analysis was conducted to identify potential hazards associated with the use and misuse of the Swiss OrthoClast®. Verification tests conducted as a result of this risk analysis include the following
- Maximum excursion and velocity of the Swiss OrthoClast® chisel tips ●
- Handpiece and chisel longevity
- In vitro cement fragmentation efficiency .
- . Orthoscope temperature elevation
The results of these tests confirmed that the Swiss OrthoClast® met the design objectives as identified by the risk analysis.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The Swiss OrthoClast® has the same intended use as the Ceboplane®, that is, removal of bone cement during implant revision surgery. The Ceboplane® is a pneumatic powered reciprocating handpiece that accepts a wide variety of osteotome chisels. A fiberoptic illuminator mounts directly on the predicate handpiece to enhance visualization for working in deep cavities. Like the Swiss OrthoClast®, the Ceboplane® uses an internal piston hammer to deliver a highenergy, short-excursion impact to the desired location under the guidance of the surgeon using either single or multiple pulse mode. Both the OrthoClast® and the Ceboplane® require only one hand to operate, unlike the traditional osteotome and mallet which require two hands, allowing the surgeon to focus on the impact sight and precisely guide the chisel tip to its optimum position.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
JUL 2 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Shelia Hemeon-Heyer, Esq., RAC Senior Staff Consultant MDCI Representing EMS SA 49 Plain Street North Attleboro, Massachusetts 02760
Re: K991588 Trade Name: Swiss OrthoClast® Regulatory Class: II Product Code: HSZ, LZV, and GET Dated: May 5, 1999 Received: May 7, 1999
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. 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.
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Page 2 - Ms. Shelia Hemeon-Heyer
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a scattering of small, dark, irregularly shaped objects against a bright white background. The objects are distributed unevenly across the frame, with a higher concentration in the upper left quadrant. The objects appear to be randomly oriented and vary slightly in size and shape.
510(k) Number (if known): _ K 991588
Device Name: EMS Swiss OrthoClast®
Indications For Use:
The EMS Swiss OrthoClast® is used for the removal of cement during implant revision surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sian-Off) Division of General Restorative Devi Kgg1598 510(k) Number
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)