(147 days)
Not Found
No
The 510(k) summary describes a reprocessed surgical blade and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a surgical tool used for specific applications within the sinus, such as cutting soft tissue and thin bone. While it assists in a medical procedure, it doesn't directly deliver therapy to treat or cure a disease itself, but rather enables the surgeon to perform therapeutic actions.
No
The device is described as a surgical blade designed for use in limited sinus applications involving soft tissue and thin bone, indicating it is an interventional or therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a physical blade, a sterile single-use device that is reprocessed. This indicates it is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that these are "Sinus Application Blades" designed for "use in limited sinus applications involving soft tissue and thin bone." This describes a surgical tool used within the body during a procedure, not a device used to analyze samples outside the body.
- Lack of Diagnostic Information: The intended use and description do not mention any diagnostic purpose or the analysis of biological samples.
This device is a surgical instrument used for a specific procedure, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Medline ReNewal Reprocessed Gyus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.
Product codes (comma separated list FDA assigned to the subject device)
NLY
Device Description
Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus
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)
The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles. Testing included: biocompatibility testing performed in accordance with ISO 10993-1:2009, cleaning validation, product stability, product performance (bench) tests included: device integrity, use and operation using simulated clinical use and artificial test soil, blade sharpness, irrigation function, and outflow function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Medline Renewal Mr. Richard D. Wynkoop Vice President Quality Assurance & Regulatory Affairs 2747 SW 6th Street Redmond, Oregon 97756
Re: K142022
Trade/Device Name: Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades Regulation Number: 21 CFR 874.4140 Regulation Name: Ear, nose, and throat bur Regulatory Class: Class I Product Code: NLY Dated: November 12, 2014 Received: November 17, 2014
Dear Mr. Wynkoop:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
for 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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Page 3 – Mr. Richard D. Wynkoop
List of models cleared in K142022:
- 7013-8000 Serrated Sinus Application Blade ●
- 7013-8001 Serrated Sinus Application Blade ●
- 7013-8002 Smooth, Round Tip Sinus Application Blade ●
- 7013-8003 Smooth, Square Tip Sinus Application Blade .
- 7013-8033 Serrated Sinus Application Blade ●
- 7013-8034 Turbinate Sinus Application Blade ●
- 7013-8035 Serrated Sinus Application Blade ●
- 7013-8100 Aggressive Sinus Application Blade ●
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Indications for Use
510(k) Number (if known) K142022
Device Name
Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades
Indications for Use (Describe)
Medline ReNewal Reprocessed Gyus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.
| 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/4/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star-like symbol to the right of it. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application
K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades
5.0 510(k) Summary
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Names | Brandi Panteleon
Director, Regulatory Affairs
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com | Richard D. Wynkoop
VP, Quality Assurance & Regulatory
Affairs
P: 541-923-3310
F: 541-923-3375
E: rwynkoop@medline.com | |
| Date Prepared | December 15, 2014 | | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Gyrus-Diego Sinus
Application Blades
Common Name: ear, nose, and throat shaver, reprocessed | | |
| Classification | § 874.4140 - ear, nose, and throat bur
Class I, nonexempt
Product Code NLY | | |
| Predicate
Device | K020594 Sinus Application Blades of the Diego Powered Dissector and
Drill System manufactured by OLYMPUS/Gyrus ACMI. | | |
| Device
Description | Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are
sterile single use devices that have been cleaned, disinfected, inspected,
refurbished, tested, packaged, labeled, and sterilized. The Medline
ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally
manufactured by OLYMPUS/Gyrus ACMI. | | |
| Statement of
Intended Use | Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are
designed for use in limited sinus applications involving soft tissue and thin
bone such as lamina papyracea. | | |
| Technological
Characteristics | The technological characteristics of the proposed devices are substantially
equivalent to the predicate devices listed in this submission. The proposed
devices are a reprocessed version of the predicate devices. | | |
| Performance
Testing | The functional characteristics of the proposed devices have been evaluated
and found to be equivalent to the predicate devices after the specified
number of reprocessing cycles. Testing included:
biocompatibility testing performed in accordance with ISO 10993-1:2009, cleaning validation, product stability, product performance (bench) tests included: device integrity, use and operation using simulated clinical use and artificial test soil, | | |
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Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application
K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades
| blade sharpness, irrigation function, and outflow function. | |
|---|---|
| Conclusion | Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate devices, Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are substantially equivalent to the predicate devices. |
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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in large font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" next to it.
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | Sinus Application Blades of the | ||
| Diego Powered Dissector and Drill | |||
| System | Medline ReNewal Reprocessed | ||
| Gyrus-Diego Sinus Application | |||
| Blades | Same device; different manufacturer | ||
| Predicate 510(k) | K020594 | TBD | N/A |
| Product Name | Gyrus-Diego Sinus Application | ||
| Blades | Reprocessed Gyrus-Diego Sinus | ||
| Application Blades | N/A | ||
| Intended Use | Gyrus Sinus Application Blades are | ||
| intended to be used with the powered | |||
| reusable hand piece of the Powered | |||
| Diego Dissector and Drill System and | |||
| are designed for use in sinus | |||
| applications. | Medline ReNewal Reprocessed | ||
| Gyrus-Diego Sinus Application | |||
| Blades are intended to be used with | |||
| the powered reusable hand piece of | |||
| the Powered Diego Dissector and | |||
| Drill System and are designed for | |||
| use in sinus applications. | Same intended use | ||
| Indications for | |||
| Use | Gyrus Sinus Application Blades are | ||
| designed for use in sinus | |||
| applications. Sinus applications | |||
| include ethmoidectomy/ | |||
| sphenoehtmoidectomy, polypectomy, | |||
| septoplasty, transsphenoidal | |||
| procedures, and procedures such as | |||
| the removal of septal spurs, | |||
| antrostomy, and endoscopic | |||
| dacryocystorhinostomy (DCR). | Medline ReNewal Reprocessed | ||
| Gyrus-Diego Sinus Application | |||
| Blades are designed for use in | |||
| limited sinus applications involving | |||
| soft tissue and thin bone such as | |||
| lamina papyracea. | Only the sinus application blades | ||
| indicated for soft tissue and thin bone | |||
| such as lamina papyracea will be | |||
| reprocessed by Medline ReNewal. The | |||
| predicate indications for use is for the | |||
| whole system, not just the sinus | |||
| application blades. Thus, the Medline | |||
| ReNewal Reprocessed Gyrus-Diego | |||
| Sinus Application Blades have a more | |||
| focused indications for use than the | |||
| predicate system. | |||
| Configuration | Insertable blades for powered | ||
| dissector and drill system | Insertable blades for powered | ||
| dissector and drill system | Same configuration |