(59 days)
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Not Found
No
The device description lists only manual surgical instruments and there is no mention of AI, ML, or image processing.
No
The device is a system of manual surgical instruments used for osteochondral grafting, which is a procedure rather than a direct therapeutic activity performed by the device itself.
No
The device description clearly states it is a "kit composed of several orthopedic manual surgical instruments" used for "osteochondral grafting." This indicates a surgical tool for treatment, not a device used to identify or diagnose a condition.
No
The device description explicitly states it is a kit composed of several orthopedic manual surgical instruments made of stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "kit composed of several orthopedic manual surgical instruments." These are tools used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of the Acufex MosaicPlasty Comprehensive System does not involve any such testing or analysis of specimens.
Therefore, the Acufex MosaicPlasty Comprehensive System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
Product codes
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Device Description
The MosaicPlasty Comprehensive System is a kit composed of several orthopedic manual surgical instruments. These instruments include drill guides, drill guide plugs, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, drill bit adapters and a sterilizing tray. All instruments are composed of stainless steel. The instruments range in diameter from 2.7 mm to 10 mm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
knee and ankle
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
DEC 2 0 1996
/5964/215
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is : _K964215
This summary was prepared on December 16, 1996
A. Submitter
Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, MA 02048
Establishment Registration Number: 1219602
B. Company Contact
Tedd Gosian Clinical / Regulatory Manager
C. Device Name
| Trade Name: | Acufex® MosaicPlasty™ Comprehensive System |
|---|---|
| Common Name: | Drill Bits, Chisels, Trephines, Tamps, Drill Guide, |
| Compression Instrument | |
| Classification Name: | Orthopedic Manual Surgical Instruments, Template |
| Surgical Instruments Motors Accessories |
Predicate/Legally Marketed Devices D.
All of the components in the MosaicPlasty Comprehensive System are Class I Exempt Devices, except drill bits and adapters which are Class I.
Predicate/Legally Marketed Devices include:
| Drill Guide | Synthes® |
|---|---|
| Drill Bits | Synthes® |
| Gouges | Synthes® |
| Trephine Drills | Smith & Nephew Endoscopy |
| Tamps | Zimmer® |
| Bone Grafter | Instrument Makar® |
| Bone Compression Forceps | KMedic® |
1
E. Device Description
The MosaicPlasty Comprehensive System is a kit composed of several orthopedic manual surgical instruments. These instruments include drill guides, drill guide plugs, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, drill bit adapters and a sterilizing tray. All instruments are composed of stainless steel. The instruments range in diameter from 2.7 mm to 10 mm.
F. Indications For Use
The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
G. Substantial Equivalence
The components of the MosaicPlasty Comprehensive System are Class I exempt devices, except drill bits and adapters which are Class I. The components are similar in design, function, materials and intended use as other devices currently in commercial distribution. All devices are composed of stainless steel. The intended use and commercially available devices are presented in the table below.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.
| Intended Use | Current Product
MosaicPlasty Comprehensive
System Components | Substantially Equivalent Product |
|----------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------|
| Drill Template | Drill Guide
Arthroscopic Drill Guide | Drill Guide
(Synthes®) |
| Use with Template | Drill Plugs
Graft Template | Drill Sleeves
(Synthes) |
| Drilling in Bone | 2.4 mm Pilot Drill Bit
2.7 mm Arthr. Drill
Arthr. Reamer Drills
Drill Bits | Drill Bits
(Synthes) |
| Harvesting Bone Grafts | Tubular Chisels | Gouges
(Synthes) |
| Cutting circular bone
section | Trephines | Trephine Drills
(Smith & Nephew Endoscopy) |
| Tamping Graft into site | Tamps
Transfer Plunger
Sculpture Stick | Tamps (Zimmer®) |
| Transferring bone graft to
recipient site | Transfer Tubes
Arthr. Transfer Tubes
Chisel Collar | Bone Grafter
(Instrument Makar®) |
2
| Adapting drill bit or
trephine to orthopedic drill | Trephine Adapters
(Quick Coupling, Power) | Quick Coupling Adapter
(Synthes) |
|-------------------------------------------------------|----------------------------------------------|---------------------------------------------|
| Compress bone block | Bone Plug Compressor | Bone Compression Forceps
(KMedic®) |
| For instrument access into
joint | Metal Cannula | Metal Cannula
(Smith & Nephew Endoscopy) |
Applicant
Tedh L. Sozan
Date 12/17/96