(61 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as having the "same technological characteristics, power modality and mode of operation as the originally cleared device."
No.
A therapeutic device is one that treats or alleviates a disease or condition. This device is described as a surgical tool for tissue removal, which is a procedural function, not a therapeutic one in itself.
No
The device is described as a shaver system intended for the removal of soft tissue and bone, which are surgical procedures, not diagnostic ones.
No
The device description explicitly refers to a "Shaver System" and mentions handpieces, indicating a physical, hardware-based medical device for surgical procedures, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting and removing tissue and bone during various ENT, head & neck, and otoneurologic procedures. This is a direct intervention on the patient's body.
- Device Description: The description focuses on the technological characteristics, power modality, and mode of operation of a surgical shaver system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for surgical intervention.
N/A
Intended Use / Indications for Use
The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny 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 transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, 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 at the cerebellopontine angle.
Product codes
77 EQJ, 77 ERL
Device Description
The modified ESSential Shaver System that is described in this notification has the same technological characteristics, power modality and mode of operation as the originally cleared device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sinus, ENT, head & neck, otoneurologic procedures, Otology procedures (mastoidectorny and mastoidotomy), Nasopharyngeal/Laryngeal procedures, maxillary and mandibular regions of the face, cerebellopontine angle.
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, ESSential Shaver System (K953096)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
Food and Drug Administration 510(k) Notification - Modified ESSential Shaver System November 11, 1997
Smith & Nephew, Inc.
2925 Appling Rd., Bartlett, TN 38133 U.S.A.
901-373-0200, Toll Free: 1-800-262-3540, Fax: 901-373-0220
For orders and order inquiries: 1-800-238-7538
510(k) Summary of Safety and Effectiveness
JAN 12 1998
| Trade Name: | ESSential® Shaver System
Modification to the ESSential® Sinus Shaver System (K953096) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrical Surgical Shaver |
| Classification Name: | Surgical ENT drill, electric or pneumatic including handpiece and
ENT burr/blades |
| Official Contact: | Deborah Arthur
Group Manager
Regulatory & Quality Assurance
Smith & Nephew, INC.
ENT Division
2925 Appling Road
Bartlett, TN 38133 |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0242 |
| Date Prepared: | November 11, 1997 |
The modified ESSential Shaver System is substantially equivalent to the Xomed XPSTM System used with the STRAIGHTSHOT™, PERFORMA™ and SKEETER™ handpieces and the ESSential Shaver System.
The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny 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 transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, laryngeal lesion debulking and tonsillectorny. Head and neck procedures would encompass soft
1
Food and Drug Administration 510(k) Notification - Modified ESSential Shaver System November 11, 1997
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 at the cerebellopontine angle.
The modified ESSential Shaver System that is described in this notification has the same technological characteristics, power modality and mode of operation as the originally cleared device. The broadened intended uses are substantially equivalent to the described predicate Xomed device. The modified ESSential Shaver System is designed to meet UL 2601-1 and IEC 601-1-2.
Differences between the modified ESSential Shaver System and the predicate devices should not affect the safety or effectiveness.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Deborah A. Arthur Group Manager Regulatory & O.A. Smith & Nephew, Inc. ENT Division 2925 Appling Road Barlett, TN 38133
Dear Ms. Arthur:
Re:
K974232 Electrical Surgical Shaver Dated: November 11, 1997 Received: November 12, 1997 Regulatory class: I 21 CFR 874.4140/Procode: 77 EQJ 21 CFR 874.4250/Procode: 77 ERL
JAN 1 2 1998
We have reviewed your Section 510(k) notification of intent to marker the device referenced above and we have decermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
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 predication 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 question 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/odrhdsmamain.html":- ------------------------------------------------------------------------------------------
Sincerely yours.
Wiliam Yri
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Food and Drug Administration 510(k) Notification - Modified ESSential Shaver System November 11, 1997
510(k) Number: Device Name: ESSential® Shaver System Modification to the ESSential® Sinus Shaver System (K953096)
Intended Use:
The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny 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 transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, 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 at the cerebellopontine angle.
Prescription Use (Per 21 CFR 801.109)
David li. Seymore
Division Sign Off
Division Sion off Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number