(119 days)
No
The device description and intended use clearly define the product as a physical sterilization tray for medical instruments, with no mention of software, data processing, or AI/ML capabilities.
No.
The device is described as a 'sterilization tray' which is a containment device for medical device sterilization, not a device used for therapeutic purposes.
No
The device is a sterilization tray used to contain medical instruments during sterilization, not to diagnose a condition.
No
The device is described as physical sterilization trays made of metal, designed to hold instruments during steam sterilization. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are "containment devices for medical device sterilization." They are designed to hold instruments during the sterilization process.
- Device Description: The description focuses on the physical construction and function of the trays for sterilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases, monitor health, or determine compatibility. This device's function is solely related to the sterilization of other medical instruments.
N/A
Intended Use / Indications for Use
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.
The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size:
REF S210GSP Description Grasping Forceps, 210mm REF 25.50014EL Description Extended Length Liberator Knife
REF S210SRF Description Suture Retrieval Forceps, 210mm REF 25.50016EL Description Extended Length Liberator Rasp
REF S210MSC Description Micro-scissors, 210mm REF C6105EL Description Extended Length Crochet Hook
REF S210AFU Description Aggressor Forcep, 15° Up, 210mm REF 8748EL Description Extended Length Knot Pusher
REF S210AFL Description Aggressor Forcep, 15° Left, 210mm REF 9837 Description Extended Length Hip Obturator
REF S210AFR Description Aggressor Forcep, 15° Right, 210mm REF A55-012-022 Description Bio Mini Revo® Blunt, Obturator
REF S210RFR Description Rotary Forcep Right, 210mm REF A55-012-023 Description Bio Mini Revo Trocar, Obturator
REF S210RGF Description Retrograde Forceps, 210mm REF A55-012-113 Description Bio Mini Revo Drill Bit
REF S210RFL Description Rotary Forcep Left, 210mm REF A55-012-130 Description Bio Mini Revo Bone Punch, 3mm
REF C6171EL Description Extended Length Drill Guide Fishmouth REF A55-012-120 Description Bio Mini Revo Tap, 3mm
REF C6172EL Description Extended Length Drill Guide Serrated REF GU1009EL Description Extended Length Katana
REF SC7900 Description Slotted Cannula, 6.7mm REF GU1004EL Description Extended Length Raven, Straight
REF SC6900 Description Slotted Cannula, 5.0mm REF 21.1001EL Description XO Button Depth Probe
Sterilize the Hip Arthroscopy Master Tray using the following parameters:
Method Steam (wrapped) Cycle Pre-vacuum Minimum Temperature 270°F(132°C) Minimum Exposure 4 minutes Minimum Dry Cycle 20 minutes
Method Steam (wrapped) Cycle Gravity Minimum Temperature 270°F(132°C) Minimum Exposure 15 minutes Minimum Dry Cycle 25 minutes
The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces.
Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments.
Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters.
Method Steam (wrapped) Cycle Pre-vacuum Minimum Temperature 270°F(132°C) Minimum Exposure 4 minutes Minimum Dry Cycle 25 minutes
Method Steam (wrapped) Cycle Gravity Minimum Temperature 270°F(132°C) Minimum Exposure 15 minutes Minimum Dry Cycle 35 minutes
CAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent wet packs when using the gravity cycle.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-the-Counter Use x (21 CFR 801 Subpart C)
Product codes
KCT
Device Description
ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitate sterilant penetration, evacuation and drying, These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although these trays are reusable they will not be serviced or repaired.
ConMed Linvatec Anodized Aluminum Sterilization Trays are available under various trade names and in various sizes and tray configurations. Interior structures of the trays have the ability to separately hold each individual instrument during the entire duration they are in contact with the trav.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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)
ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY), K080531
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for CONMED LINVATEC. The logo is black and white and includes the company name in a bold, sans-serif font. Below the name is the text "L I N V A T E C" in a smaller font. The image also includes the address "11311 Concept Boulevard • Largo, FL 33773-4908", the phone number "727-392-6464", and the website "www.linvatec.com".
510(k) Summary ConMed Linvatec Anodized Aluminum Sterilization Trays
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting a 510(k) Summary of Safety and Effectiveness for 510(k) Number_ 1090560
| Submitter | ConMed Linvatec
11311 Concept Blvd.
Largo, Florida 33773-4908
Establishment Registration Number 1017294 | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | JUN 29 2009 |
| Company Contact | Rebecca Roberts, RAC
Regulatory Affairs Specialist
Telephone 727-399-5564
Fax 727-399-5264 | |
| Family Name | ConMed Linvatec Anodized Aluminum
Sterilization Trays | |
| Device Name | Hip Arthroscopy Master Tray, ST7900
PowerPro Small System Sterilization Case, PRO5095
Hall Sterilization Tray, PRO6000 | |
| Classification Name | Sterilization Wrap Containers, Cassettes and
other Accessories | |
| & Regulation number | 21 CFR 880.6850
Infection Control Devices Branch | |
| Proposed Class/Device | Class II | |
| Product Code | KCT | |
| Predicate Device | ConMed Linvatec Microfracture Instrument
Sterilization Tray (MFX-TRAY), K080531 | |
Device Description
ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitate sterilant penetration, evacuation and drying, These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of
1
Image /page/1/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo consists of the word "CONMED" in large, bold letters, with the word "LINVATEC" underneath in smaller letters. Below the logo is the address "11311 Concept Boulevard, Largo, FL 33773-4908", followed by the phone number "727-392-6464" and the website "www.linvatec.com".
510(k) Summary ConMed Linvatec Anodized Aluminum Sterilization Trays
the contents. Although these trays are reusable they will not be serviced or repaired.
ConMed Linvatec Anodized Aluminum Sterilization Trays are available under various trade names and in various sizes and tray configurations. Interior structures of the trays have the ability to separately hold each individual instrument during the entire duration they are in contact with the trav.
Intended Use:
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.
The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size:
| REF | Description | REF | Description |
|---|---|---|---|
| S210GSP | Grasping Forceps, 210mm | 25.50014EL | Extended Length Liberator Knife |
| S210SRF | Suture Retrieval Forceps, 210mm | 25.50016EL | Extended Length Liberator Rasp |
| S210MSC | Micro-scissors, 210mm | C6105EL | Extended Length Crochet Hook |
| S210AFU | Aggressor Forcep, 15° Up, 210mm | 8748EL | Extended Length Knot Pusher |
| S210AFL | Aggressor Forcep, 15° Left, 210mm | 9837 | Extended Length Hip Obturator |
| S210AFR | Aggressor Forcep, 15° Right, 210mm | A55-012-022 | Bio Mini Revo® Blunt, Obturator |
| S210RFR | Rotary Forcep Right, 210mm | A55-012-023 | Bio Mini Revo Trocar, Obturator |
| S210RGF | Retrograde Forceps, 210mm | A55-012-113 | Bio Mini Revo Drill Bit |
| S210RFL | Rotary Forcep Left, 210mm | A55-012-130 | Bio Mini Revo Bone Punch, 3mm |
| C6171EL | Extended Length Drill Guide Fishmouth | A55-012-120 | Bio Mini Revo Tap, 3mm |
| C6172EL | Extended Length Drill Guide Serrated | GU1009EL | Extended Length Katana |
| SC7900 | Slotted Cannula, 6.7mm | GU1004EL | Extended Length Raven, Straight |
| SC6900 | Slotted Cannula, 5.0mm | 21.1001EL | XO Button Depth Probe |
2
Image /page/2/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo features a stylized "C" shape on the left, followed by the text "CONMED" in bold, sans-serif font. Below the company name is the word "LINVATEC" in a smaller font. The address "11311 Concept Boulevard, Largo, FL 33773-4908" and contact information "727-392-6464" and website "www.linvatec.com" are listed below the company name.
510(k) Summary ConMed Linvatec Anodized Aluminum Sterilization Trays
Sterilize the Hip Arthroscopy Master Tray using the following parameters:
| Method | Cycle | Minimum
Temperature | Minimum Exposure | Minimum Dry Cycle |
|-----------------|------------|------------------------|------------------|-------------------|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 20 minutes |
| Steam (wrapped) | Gravity | 270°F(132°C) | 15 minutes | 25 minutes |
The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces.
Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments.
Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters.
| Method | Cycle | Minimum
Temperature | Minimum Exposure | Minimum Dry Cycle |
|-----------------|------------|------------------------|------------------|-------------------|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 25 minutes |
| Steam (wrapped) | Gravity | 270°F(132°C) | 15 minutes | 35 minutes |
CAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent wet packs when using the gravity cycle.
Substantial Equivalence
The proposed and the predicate devices are substantially equivalent in design. materials and intended use. The proposed devices and the predicate devices are containment devices for sterilization of reusable medical devices using steam sterilization. The proposed devices present no new issues of safety and efficacy.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and a caduceus, a symbol of medicine, is visible in the lower right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Public Health Service
JUN. 29 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Robecca Roberts Regulatory Affairs Specialist ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908
. Re: K090560
Trade/Device Name: Hip Arthroscopy Master Tray (ST7900) PowerPro® Small System Sterilization Case, PRO5095, Hall Sterilization Tray, PRO6000 Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 16, 2009 Received: June 17, 2009
Dear Ms. Roberts:
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 (PMA), it may be subject to 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. .
4
Page 2- Mr. Roberts
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation. Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| 510(k) Number (if known): | K090560/S001 |
|---|---|
| Family Name: | ConMed Linvatec Anodized Aluminum Sterilization Trays |
| Trade Name: | PowerPro® Small System Sterilization Case, PRO5095 |
| Hall® Sterilization Tray, PRO6000 |
Indications for Use:
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.
The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces.
Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments.
Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters.
| Method | Cycle | Minimum
Temperature | Minimum Exposure | Minimum Dry Cycle |
|-----------------|------------|------------------------|------------------|-------------------|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 25 minutes |
| Steam (wrapped) | Gravity | 270°F(132°C) | 15 minutes | 35 minutes |
CAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent wet packs when using the gravity cycle.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use × (21 CFR 801 Subpart C)
(PLÉASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Charles H. Murphree, M.D. | |
|---|---|
| -- | ---------------------------------------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091
6
INDICATIONS FOR USE
510(k) Number (if known): K090560
Family Name:
ConMed Linvatec Anodized Aluminum Sterilization Trays
Trade Name:
Hip Arthroscopy Master Tray (ST7900)
Indications for Use:
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.
The Hip Arthroscopy Master Tray is intended for use only with the following instruments:
| REF | Description | REF | Description |
|---|---|---|---|
| S210GSP | Grasping Forceps | 25.50014EL | EL Liberator |
| S210SRF | Suture Retrieval | 25.50016EL | EL Rasp |
| S210MSC | Micro-scissors | C6105EL | EL Crochet Hook |
| S210AFU | Aggressor Forcep Up | 8748EL | EL Knot Pusher |
| S210AFL | Aggressor Forcep Left | 9837 | EL Hip Obturator |
| S210AFR | Aggressor Forcep Right | A55-012-022 | BMR Obturator, Blunt |
| S210RFR | Rotary Forcep Right | A55-012-023 | BMR Obturator, Trocar |
| S210RGF | Retrograde Forceps | A55-012-113 | BMR Drill Bit |
| S210RFL | Rotary Forcep Left | A55-012-130 | BMR Bone Punch |
| C6171EL | EL Drill Guide Fishmouth | A55-012-120 | BMR Tap |
| C6172EL | EL Drill Guide Serrated | GU1009EL | EL Katana |
| SC7900 | Slotted Hip Cannula, 6.7mm | GU1004EL | EL Raven, Straight |
| SC6900 | Slotted Hip Cannula, 5.0mm | 21.1001EL | EL Probe |
Shale H. Maugher, D
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K90 562 C