(270 days)
Not Found
No
The 510(k) summary describes a motorized surgical device for cutting, drilling, and debriding tissue and bone. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML capabilities. The performance studies focus on system verification and validation, not on the performance of an AI/ML algorithm.
No
The device is described as a surgical system used for cutting, drilling, and debriding tissue/bone, which are surgical interventions, not therapeutic treatments.
No
The device is described as a "motorized surgical device system" intended for "controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures," indicating it is an interventional or therapeutic device, not diagnostic.
No
The device description explicitly states it is a "motorized surgical device system, consisting of an active control unit used in combination with: the High-Speed Micro Motor and attaching handpiece and the DrillCut-X® II Shaver handpiece". This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description reinforces this by calling it a "motorized surgical device system" used for "controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the UNIDRIVE® S III ENT system is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpiece. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
Product codes
ERL
Device Description
The UNIDRIVE® S III ENT is a motorized surgical device system, consisting of an active control unit used in combination with: the High-Speed Micro Motor and attaching handpiece and the DrillCut-X® II Shaver handpiece (with optional attaching handle). The surgical device system provides controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, ENT, or otoneurological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Nonclinical performance characteristics evaluated in support of the substantial equivalence of the UNIDRIVE® S III ENT include system verification and validation testing. Study results demonstrate adherence to design specifications. Experiments yielded consistent results. Consistent test conditions were maintained throughout the study. Performance testing reports are provided in the Performance Testing (Bench) of this 510(k). Cleaning and sterilization validations were conducted for patient-contacting components.
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
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2016
Karl Storz Endoscopy America, Inc. Jennifer Chambers Regulatory Affairs Specialist 2151 E. Grand Ave El Segundo, California 90245
Re: K150969
Trade/Device Name: Unidrive S IIi Ent 40701601-1 With Karl Storz-scb, Drillcut-x II Shaver Handpiece, High Speed Ec Micromotor II For Use With Intra Drill Handpieces Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, And Throat Electric Or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: December 4, 2015 Received: December 8, 2015
Dear Ms. Chambers:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name UNIDRIVE S III ENT
Indications for Use (Describe)
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpiece. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for STORZ. The logo is in blue and consists of the word "STORZ" in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in smaller letters.
7. 510(k) Summary
Traditional Premarket Notification Submission (510(k)) Summary Prepared in accordance with 21 CFR 807.92
7.1 Submitter Information
| Sponsor name: | KARL STORZ Endoscopy America, Inc. |
|---|---|
| Sponsor address: | 2151 E. Grand Ave. |
| El Segundo, CA 90245 USA | |
| Sponsor telephone: | 424-218-8100 |
| Sponsor fax: | 424-218-8519 |
| Establishment Registration: | 3010202439 |
| Contact person: | Jennifer Michelle Chambers
MPA, MBA, CCRP, CQA, PMP, RAC (US) |
|------------------------|------------------------------------------------------------------|
| Contact title: | Regulatory Affairs Specialist |
| Email direct: | jennifer.chambers@karlstorz.com |
| Telephone direct: | 424-218-8457 |
| Date summary prepared: | March 31, 2015 |
| Date summary updated: | January 5, 2016 |
7.2 Device Name
| Trade (proprietary): | UNIDRIVE S III ENT |
|---|---|
| Common (usual): | Drill, Surgical, ENT (Electric Or Pneumatic) Including Handpiece |
| Classification: | 21 CFR 874.4250 (Class II) |
| FDA Device Code: | ERL: Ear, nose, and throat electric or pneumatic surgical drill |
| Review Panel: | 77 (Ear Nose & Throat) |
7.3 Substantially Equivalent Predicate Device
| Device Name: | KSEA UNIDRIVE ENT System and Accessories |
|---|---|
| Device 510(k): | K053262 |
7.4 Device Description
The UNIDRIVE® S III ENT is a motorized surgical device system, consisting of an active control unit used in combination with: the High-Speed Micro Motor and attaching handpiece and the DrillCut-X® II Shaver handpiece (with optional attaching handle). The surgical device system provides controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
4
7.5 Intended Use
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpiece. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
7.6 Technological Characteristics
The UNIDRIVE® S III ENT system and the predicate UNIDRIVE ENT system are both motorized, reusable surgical device systems, used in conjunction with drills, handpieces, blades, and burs. Both systems provide controlled cutting, drilling, sawing, and removal of bone during head, neck, ENT, and or otoneurological surgical procedures. The performance of the new device has undergone system verification and validation testing to ensure it does not introduce new issues of safety or effectiveness.
7.7 Performance Characteristics
Nonclinical performance characteristics evaluated in support of the substantial equivalence of the UNIDRIVE® S III ENT include system verification and validation testing. Study results demonstrate adherence to design specifications. Experiments vielded consistent results. Consistent test conditions were maintained throughout the study. Performance testing reports are provided in the Performance Testing (Bench) of this 510(k). Cleaning and sterilization validations were conducted for patient-contacting components.
7.8 Cleaning and Sterilization
Reusable instruments (i.e. DrillCut-X® II Shaver handpiece, High-Speed Micro Motor and handpieces, plus compatible Straight Shaver Blades) are delivered non-sterile and must be cleaned and sterilized prior to the initial use and before each subsequent use. Compatible sinus burrs and disposable tubings are sterile, single-use products and must be disposed of after patient use. Sterility efficacy demonstrated a sterility assurance level of 106 in a pre-vacuum steam sterilizer. Manual cleaning effectiveness was demonstrated with sufficient recovery efficiency for residual protein and residual hemoglobin.
7.9 Animal and Clinical Performance Data:
Animal and Clinical performance data are not required to demonstrate substantial equivalence for this type of device.
7.10 Conclusion
Based on the information provided in this premarket notification. KARL STORZ concludes that the UNIDRIVE® S III ENT is safe, effective, and substantially equivalent to the predicate UNIDRIVE ENT in its indication for use, device design, materials, performance characteristics, and operational principles.