(77 days)
Not Found
Not Found
No
The summary describes a surgical cutting and removal system with an integrated irrigation pump, focusing on mechanical function and substantial equivalence to predicate devices. There is no mention of AI or ML capabilities.
Yes.
The device's intended use is the cutting and removal of bone and tissue, which are actions performed to treat a medical condition.
No.
The "Intended Use / Indications for Use" section explicitly states that "The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue," which describes a surgical or therapeutic function, not a diagnostic one.
No
The device description explicitly mentions a "controller unit" with an integrated "irrigation pump," indicating the presence of hardware components beyond just software.
Based on the provided text, the Turbo 7000™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures." This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a system with handpieces and an irrigation pump, designed for surgical procedures. It also references standards related to medical electrical equipment used on patients (UL 2601-1, CSA 22.2 No. 601-1-1, EN 60601-1, IEC 601-1-2, EN 60601-1-2, IEC 529).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Turbo 7000™ System is a surgical instrument used during procedures on the body.
N/A
Intended Use / Indications for Use
The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures.
Otology procedures would include:
- mastoidectomy and ●
- mastoidotomy. .
Sinus applications would embody:
- septoplasty and .
- . procedures such as
- . the removal of septal spurs,
- polypectomy, .
- antrostomy, .
- ethmoidectomy/sphenoethmoidectomy, .
- frontal sinus trephination and irrigation, .
- frontal sinus drill out, .
- endoscopic DCR and .
- trans-spehnoidal procedures. .
Nasopharyngeal/Laryngeal procedures would comprise:
- adenoidectomy, .
- . tracheal,
- laryngeal polyectomy, .
- laryngeal lesion debulking and .
- tonsillectomy. .
Head and neck procedures would encompass:
- . soft tissue shaving,
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), .
- removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of . the face, and
- . acoustic neuroma removal.
Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.
Product codes
874.4250
Device Description
The Turbo 7000™ System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ENT, head & neck, otoneurologic, mastoid, sinus, nasopharyngeal, laryngeal, maxillary and mandibular regions of the face
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)
Xomed XPSTM System, Modified ESSential Shaver
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
Food and Drug Administration 510(k) Notification - The Turbo 7000™ System September 3, 1999
q 2994
NOV 2 3 1999
ppling Rd., Bartlett, TN 38 0200. Toll Free: 1 orders and order inquiri
510(k) Summary of Safety and Effectiveness
| Trade Name: | The Turbo 7000™ System |
|---|---|
| Common Name: | Electrical Surgical Drill/Shaver |
| Classification Name: | Surgical ENT drill, electric or pneumatic including handpieces and |
| ENT burr/blades | |
| Official Contact: | Jeff Cobb |
| Group Director | |
| Regulatory, Clinical & Quality Assurance | |
| Smith & Nephew, INC. | |
| ENT Division | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0242 |
| Date Prepared: | September 3, 1999 |
The Turbo 7000™ System is substantially equivalent to the Xomed XPSTM System used with the STRAIGHTSHOT™, PERFORMATM and SKEETER™ handpieces, and the Modified ESSential Shaver.
The Turbo 7000 System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures would include mastoidectomy and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the the removal of of of septal spurs. polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and trans-sphenoidal procedures. Nasopharyngeal procedures would comprise adenoidectomy, tracheal, laryngeal polyectomy, larvngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass soft tissue shaving, thinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Additionally, an irrigation pump will be included as a component of the system to provide irrigant in conjunction with the procedures.
1
Food and Drug Administration 510(k) Notification -- The Turbo 7000™ System September 3, 1999
The Turbo 7000 System that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate devices. The intended uses are substantially equivalent to the described predicate Modified ESSential Shaver System and the Xomed System. The Turbo 7000 System is designed to meet UL 2601-1 including German Deviations and Australian Deviations, CSA 22.2 No. 601-1-1 (EN 60601-1), IEC 601-1-2(EN 60601-1-2) and IEC 529.
Differences between the Turbo 7000 System and the predicate devices should not affect the safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.
od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Mr. Jeff Cobb Group Director Regulatory, Clinical & Quality Assurance Smith & Nephew, Inc. ENT Division 2925 Appling Road Bartlett, TN 38133
Re: K992994
Trade Name: The Turbo 7000™ Regulatory Class: II Product Code: 874.4250 Dated: September 3, 1999 Received: September 7, 1999
Dear Cobb:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Cobb
· This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Food and Drug Administration 510(k) Notification - The Turbo 7000™ System September 3, 1999
K992994 510(k) Number: Device Name: The Turbo 7000™ System
Intended Use:
The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures.
Otology procedures would include:
- mastoidectomy and ●
- mastoidotomy. .
Sinus applications would embody:
- septoplasty and .
- . procedures such as
- . the removal of septal spurs,
- polypectomy, .
- antrostomy, .
- ethmoidectomy/sphenoethmoidectomy, .
- frontal sinus trephination and irrigation, .
- frontal sinus drill out, .
- endoscopic DCR and .
- trans-spehnoidal procedures. .
Nasopharyngeal/Laryngeal procedures would comprise:
- adenoidectomy, .
- . tracheal,
- laryngeal polyectomy, .
- laryngeal lesion debulking and .
- tonsillectomy. .
Head and neck procedures would encompass:
- . soft tissue shaving,
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), .
- removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of . the face, and
- . acoustic neuroma removal.
Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.
Prescription Use
(Per 21 CFR 801.109)
Page 3
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K99299
K992994