(174 days)
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No
The document describes reprocessed surgical shavers and their intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is intended for use in various surgical procedures involving the removal of bone and tissue, which directly contributes to the treatment or amelioration of a disease or condition.
No
The device description indicates that the ENT shavers are "powered dissectors inserted into a reusable hand piece and designed to be used in the removal of bone and tissue in various ENT, head and neck surgeries, and otoneurologic procedures." This describes a surgical tool used for treatment, not for diagnosing a condition.
No
The device description explicitly states it is a "powered dissector" and mentions "removal of bone and tissue," indicating a physical, hardware-based device. The submission is for the reprocessed shaver itself, not software controlling it.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that these are "powered dissectors inserted into a reusable hand piece and designed to be used in the removal of bone and tissue in various ENT, head and neck surgeries, and otoneurologic procedures." This involves direct surgical intervention within the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical tool used for tissue removal during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures.
Sinus Applications:
- Polypectomy .
- Ethmoidectory/Sphenoethmoidectomy
- Septoplasty
- Antrostomy
- Endoscopic DCR .
- Frontal Sinus Trephination and Irrigation
- Frontal Sinus Drill Out
- Septal Spur Removal
- Trans-Sphenoidal Procedures
Head and Neck Procedures - Rhinoplasty .
- Lipodebridement in the Maxillary and Mandibular Region .
- Soft Tissue Shaving
- Acoustic Neuroma Removal
Nasopharyngeal and Laryngeal Procedures - Tonsillectomy .
- Tracheal Procedures .
- Adenoidectomy
- Laryngeal Lesion De-Bulking
- Laryngeal Polypectomy .
Otology Procedures - Mastoidotomy .
- Mastoidectomy
Product codes (comma separated list FDA assigned to the subject device)
ERL
Device Description
SterilMed's reprocessed ENT shavers are powered dissectors inserted into a reusable hand piece and designed to be used in the removal of bone and tissue in various ENT, head and neck surgeries, and otoneurologic procedures. These devices were originally manufactured by Gyrus and Medtronic.
Note: Only the shaver is the subject of this submission, the reusable hand piece and any other related equipment are not included in the scope of this submission.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear, Nose, Throat, Head, Neck, Sinuses, Nasopharyngeal, Laryngeal, Mastoid
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed ENT shavers were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."
510(K) PREMARKET NOTIFICATION SUBMISSION JUNE 25, 2008 FOR REPROCESSED ENT SHAVERS
SUMMARY AND CERTIFICATION II.
DEC 1 7 2008
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Joshua Clarin |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 612-644-8402 | |
| Fax: 763-488-3350 | |
| Date Prepared: | June 25, 2008 |
| Trade Name: | Reprocessed ENT Shavers |
| Classification Name: | Ear, Nose and Throat Electrical or Pneumatic Surgical Drill |
| Classification Number: | Class II, 21 CFR 874.4250 |
| Product Code: | ERL |
| Predicate
Devices: | The reprocessed ENT shavers are substantially equivalent to Gyrus Diego® and Medtronic
Xomed XPS® shavers. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed's reprocessed ENT shavers are powered dissectors inserted into a reusable hand
piece and designed to be used in the removal of bone and tissue in various ENT, head and neck
surgeries, and otoneurologic procedures. These devices were originally manufactured by Gyrus
and Medtronic. |
| | Note: Only the shaver is the subject of this submission, the reusable hand piece and any other
related equipment are not included in the scope of this submission. |
| Intended Use: | The reprocessed ENT shavers are intended to be used with a reusable hand piece and are
designed for use in various ENT, head and neck surgeries, and otoneurologic procedures. |
| Functional and
Safety Testing: | Representative samples of reprocessed ENT shavers were tested to demonstrate appropriate
functional characteristics. Process validation testing was performed to validate the cleaning and
sterilization procedures as well as device packaging. In addition, the manufacturing process
includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed ENT shavers are substantially equivalent to Gyrus Diego® and Medtronic
Xomed XPS® blades. |
| | This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use and methods of construction. |
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Image /page/1/Picture/0 description: The image shows the logo for SterilMed INC. The logo is in bold, black font. Underneath the company name, it says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair".
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510(K) PREMARKET NOTIFICATION SUBMISSION JUNE 25, 2008 FOR REPROCESSED ENT SHAVERS
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B. Premarket Notification Statement
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In lieu of a Premarket Notification Statement, a 510(k) Summary has been provided. Refer to Section II.A for 510(k) summary and certification.
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1999 - 1999
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CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed. Inc. c/o Dennis Toussaint Director Regulatory Affairs 11400 73rd Avenue, N. Suite 100 Maple Grove, MN 55369
DEC 1 7 2008
K081814 Re: Trade/Device Name: Reprocessed ENT Shavers 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 12, 2008 Received: December 15, 2008
Dear Mr. Toussaint:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egolints, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_K081814
Device Name: Reprocessed ENT Shavers
Indications for Use:
Indications tor Use:
The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures.
Sinus Applications:
- Polypectomy .
- Ethmoidectory/Sphenoethmoidectomy
- Septoplasty
- Antrostomy
- Endoscopic DCR .
- Frontal Sinus Trephination and Irrigation
- Frontal Sinus Drill Out
- Septal Spur Removal
- Trans-Sphenoidal Procedures
Head and Neck Procedures
- Rhinoplasty .
- Lipodebridement in the Maxillary and Mandibular Region .
- Soft Tissue Shaving
- Acoustic Neuroma Removal
Nasopharyngeal and Laryngeal Procedures
- Tonsillectomy .
- Tracheal Procedures .
- Adenoidectomy
- Laryngeal Lesion De-Bulking
- Laryngeal Polypectomy .
Otology Procedures
- Mastoidotomy .
- Mastoidectomy
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sir Nadler
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K081814
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K081814
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Carlos Concession
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| Manufacturer | Model # |
|---|---|
| Gyrus | 7013-8100 |
| 7013-8000 | |
| 7013-8035 | |
| 7013-8001 | |
| 7013-8002 | |
| 7013-8003 | |
| Medtronic Xomed | 18-84004HR |
| 18-84004 | |
| 18-83504HR | |
| 18-83504 | |
| 18-82904HRE | |
| 18-82904 | |
| 18-84002HRE | |
| 18-84002 | |
| 18-83502HRE | |
| 18-83502 | |
| 18-82902HRE | |
| 18-82902 | |
| 18-84005HRE | |
| 18-84005 | |
| 18-82905HRE | |
| 18-82905 | |
| 18-82040HR | |
| 18-82040 | |
| 18-82940HR | |
| 18-82940 |
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List of Devices included in this Premarket Notification Submission - 510(k) K081814
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