(124 days)
Not Found
No
The device is a surgical instrument tray for storage, sterilization, and transport, with no mention of AI/ML capabilities in the description or performance studies.
No
The device is an instrument tray intended for storage, sterilization, and transport of surgical instruments. It does not directly treat, cure, mitigate, or prevent disease.
No
The device is an instrument tray used for the storage, sterilization, and transport of surgical instruments. It does not perform any diagnostic function.
No
The device description clearly states it is a stainless steel tray with physical components (instrument holders, pin mat, tiers) designed for containing and protecting surgical instruments during transport, sterilization, and storage. It is a physical hardware device.
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 tray is for containing, organizing, sterilizing, and transporting reusable surgical instruments. It is not intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on the physical characteristics of the tray and its function in holding and protecting surgical instruments during sterilization and transport.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices. The performance studies focus on sterilization and functional strength, not diagnostic accuracy or performance.
Therefore, this device is a surgical instrument tray, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in pre-vacuum steam sterilization method. The subject instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum steam | 132° C (270° F) | 4 minutes | 45 minutes |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
Smith & Nephew Hip Arthroscopy Repair Instrument Repair Tray is a stainless steel tray provided with instrument holders, pin mat, and tiers. The tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
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)
Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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
K102544 >
4
Page 2 – Ms. Solomon
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 regions . 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53) -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 phone;" (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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew Hip Arthroscopy Repair Instrument Tray
Indications For Use: Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in pre-vacuum steam sterilization method. The subject instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum | |||
| steam | 132° C | ||
| (270° F) | 4 minutes | 45 minutes |
Device model that is the subject of this pre-market notification:
| REF | Description |
|---|---|
| 72202732 | Hip Arthroscopy Repair Instrument Tray |
Prescription Use
AND/OR
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
Over-The-Counter Use X
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ealyabeth S. Clanni-Willen
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number. K102544
Smith & Nephew Hip Arthroscopy Repair Instrument Tray
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