(77 days)
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.
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 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.
Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.
Here's a breakdown of the acceptance criteria and study information for the Turbo 7000™ System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity). Instead, the basis for clearance is substantial equivalence to predicate devices. The document focuses on demonstrating that the Turbo 7000™ System has similar technological characteristics, power modality, mode of operation, and intended uses as the predicate devices, and that differences do not affect safety or effectiveness.
Therefore, the "acceptance criteria" here are qualitative and relate to regulatory compliance and equivalence to established devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Equivalence: Same technological characteristics, power modality, and mode of operation as predicate devices. | "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." |
| Intended Use Equivalence: Substantially equivalent intended uses to predicate devices. | "The intended uses are substantially equivalent to the described predicate Modified ESSential Shaver System and the Xomed System." (Detailed intended uses listed, matching the general applications of surgical drills/shavers in ENT, head & neck, and otoneurologic procedures). |
| Safety and Effectiveness: Differences from predicate devices should not affect safety or effectiveness. | "Differences between the Turbo 7000 System and the predicate devices should not affect the safety or effectiveness." (This is a claim, not a quantified measurement of performance.) |
| Regulatory Compliance: Designed to meet relevant safety standards. | "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." |
| Substantial Equivalence Determination by FDA: FDA review and determination of substantial equivalence to legally marketed predicate devices. | "We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (FDA's final decision confirms this criterion was met.) |
| Predicate Devices: Xomed XPS™ System (with STRAIGHTSHOT™, PERFORMA™, and SKEETER™ handpieces) and the Modified ESSential Shaver. | The document states 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." |
| General Controls Provisions of the Act: Compliance with regulations for annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. | The FDA letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the manufacturer is expected to comply with these, as is standard for 510(k) clearance. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not describe a specific clinical or performance test set with a sample size. The 510(k) submission for the Turbo 7000™ System is based on demonstrating substantial equivalence to existing predicate devices through comparison of design, materials, and intended use, rather than a new clinical study. There is no mention of a "test set" and consequently no provenance information (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as no specific "test set" or ground truth establishment by experts is described in the provided 510(k) summary. The ground truth for this type of submission is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as no "test set" requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. The Turbo 7000™ System is an electrical surgical drill/shaver, not an AI-assisted diagnostic or imaging system. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Turbo 7000™ System is a hardware device (surgical drill/shaver) and does not involve algorithms or standalone performance analysis in the context of AI. It operates with a human surgeon in the loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness profile of the predicate devices. The applicant is asserting that the new device is as safe and effective as these already legally marketed devices, rather than establishing a new ground truth for a novel claim.
8. The sample size for the training set
This information is not applicable as there is no "training set" mentioned or implied for this type of device submission. The device is not based on a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for the Turbo 7000™ System.
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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 andENT burr/blades |
| Official Contact: | Jeff CobbGroup DirectorRegulatory, Clinical & Quality AssuranceSmith & Nephew, INC.ENT Division2925 Appling RoadBartlett, 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.
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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.
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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
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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
§ 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.