(90 days)
Not Found
No
The summary describes surgical instruments for ACL reconstruction and does not mention any AI or ML components or capabilities.
Yes
The ACL instruments are used for the reconstruction of anterior cruciate ligament, which is a therapeutic intervention aimed at restoring function.
No
Explanation: The device is described as an instrument used for the reconstruction of the anterior cruciate ligament, specifically for removing the patellar ligament and facilitating the press-fit technique. Its function is interventional/surgical, not diagnostic.
No
The device description clearly indicates it is a set of physical instruments used for surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical reconstruction of the anterior cruciate ligament using a specific technique. This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as instruments for removing and preparing bone plugs for surgical implantation. This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique.
- · The drill alignment device ensures precise drilling of the tibial channel.
- · The pneumatic drill drives the oscillating hollow drills.
- · The short hollow drill is used for graft removal from the ligament.
- The long hollow drill with ejector is used for removing the tibial bone plug used for filling in the graft-removal defects on the patella and the tibia.
- · The eiector ensures the correct drilling direction and permits subsequent eiection of the bone for the hollow drill.
Product codes
Not Found
Device Description
The ACL instrument by Boszotta allows fast and standardized removal of the patellar ligament by an optimal arthroscopic press-fit technique. The standardized diameter of the bone plugs allows optimum bone contact and promotes rapid healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cruciate ligament, patellar ligament, tibial channel, patella, tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
The ACL Instruments by Boszotta have been used in Eisenstadt Hospital for accident cases for about three years. During this time the instruments were used in more than 200 routine interventions. At this time, no mechanical problems or biological incompatibility reactions have been reported. The steam sterilization following each operation do not show any problems.
Key Metrics
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
Richard Wolf Medical Instruments Corporation
APR 2 9 1997
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
| 510(k) Summary of Safety and Effectiveness |
|---|
| -------------------------------------------- |
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | January 24, 1997 |
|---|---|
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| ZIP / Postal Code: | 60061 |
| Product Information: | |
|---|---|
| Trade name: | ACL instruments and instrumentation |
| Model number: | 8869.011 8869.111 8869.151 8869.152 8869.911 8869.841 8869.842 |
| Common name: | ACL instruments |
| Classification name: | Endoscope and accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K940125 | 1 ACL-Drill Guide Instrument, type 8870.152 | 1 Richard Wolf |
| 2 | 2 Alignment instrument, type 8731 | 2 Linvatec | |
| 3 | 3 Alignment instrument, type AR 1875 | 3 Arthrex | |
| 4 | 4 Pneumatic drill, type GA 207 | 4 Aesculap | |
| 5 | 5 Coring Reamer, type AR-1223CR | 5 Arthrex | |
| 6 | 6 | 6 |
1.0 Description
The ACL instrument by Boszotta allows fast and standardized removal of the patellar ligament by an optimal arthroscopic press-fit technique. The standardized diameter of the bone plugs allows optimum bone contact and promotes rapid healing.
Image /page/0/Picture/7 description: The image shows the logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" on top and "WOLF" below. To the right of the text is a square containing a stylized image of a wolf. The wolf is drawn with simple lines and has a distinctive tail.
参考文献 - 文章
1
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
2.0 Intended Use
The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique.
- · The drill alignment device ensures precise drilling of the tibial channel.
- · The pneumatic drill drives the oscillating hollow drills.
- · The short hollow drill is used for graft removal from the ligament.
- The long hollow drill with ejector is used for removing the tibial bone plug used for filling in the graft-removal defects on the patella and the tibia.
- · The eiector ensures the correct drilling direction and permits subsequent eiection of the bone for the hollow drill.
Technological Characteristics 3.0
- The drill alignment device ensures precise drilling of the tibial channel at an angle of 40-45° to the axis of the tibial shaft to achieve sufficient dorsal positioning of the femoral channel. It includes a small standard drill guide for a drilling wire and a large drill guide for a hollow drill.
- The pneumatic drill works has a 5-cell lamellar motor with oscillation head and fingercontrolled speed adjustment. It drives hollow drills with oscillation frequency up to 3400 rom and oscillating motion angle of ± 20°.
- The hollow drills consist essentially of an oscillating hollow tube, which rotates about its longitudinal axis. Three quarters of the circumference of the cutting edge of the hollow drill is toothed. The segment of the hollow drill facing the ligament is rounded. The closed shape with a scale on the outer surface standardizes the diameter and the removal depth of the bone plugs.
All ACL instruments are autoclavable (steam sterilization) for high hygiene demands.
4.0 Substantial Equivalence
The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf and/or sold by competitors.
5.0 Performance Data
The ACL Instruments by Boszotta have been used in Eisenstadt Hospital for accident cases for about three years. During this time the instruments were used in more than 200 routine interventions. At this time, no mechanical problems or biological incompatibility reactions have been reported. The steam sterilization following each operation do not show any problems.
.0 Clinical Tests
No clinical tests performed.
Image /page/1/Picture/20 description: The image shows the logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" on top and "WOLF" on the bottom. To the right of the words is a square with a stylized image of a wolf inside. The wolf is drawn with simple lines and has a distinctive tail.
2
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
7.0 Conclusions Drawn
Conclusions Drawn These devices as the instruction manual.
.
By: Robert L. Cesare
Robert L. Casarsa Quality Assurance Manager
Date: Ion 24, 97
Image /page/2/Picture/7 description: The image shows the logo for Richard Wolf. The text "RICHARD" is stacked on top of the text "WOLF". To the right of the text is a logo that appears to be the letters "RW" inside of a rounded square.