← Product Code [NLY](/submissions/EN/subpart-e%E2%80%94surgical-devices/NLY) · K142022 # MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES (K142022) _Medline Renewal · NLY · Dec 19, 2014 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/NLY/K142022 ## Device Facts - **Applicant:** Medline Renewal - **Product Code:** [NLY](/submissions/EN/subpart-e%E2%80%94surgical-devices/NLY.md) - **Decision Date:** Dec 19, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4140 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Indications for 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. ## Device Story Reprocessed Gyrus-Diego sinus application blades; sterile, single-use devices. Original manufacturer: OLYMPUS/Gyrus ACMI. Device functions as insertable blades for powered reusable handpiece of Diego Powered Dissector and Drill System. Used in clinical settings for sinus procedures involving soft tissue and thin bone. Medline ReNewal process includes cleaning, disinfection, inspection, refurbishment, testing, packaging, labeling, and sterilization. Output is mechanical cutting/dissection of tissue/bone during surgery. Benefits include providing reprocessed surgical instruments for sinus applications. ## Clinical Evidence Bench testing only. Testing included biocompatibility per ISO 10993-1:2009, cleaning validation, product stability, and product performance (device integrity, simulated clinical use, artificial test soil, blade sharpness, irrigation function, and outflow function). ## Technological Characteristics Insertable blades for powered dissector and drill system. Reprocessed version of predicate. Materials and design identical to original manufacturer specifications. Sterilization performed as part of reprocessing cycle. ## Regulatory 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. ## Predicate Devices - Sinus Application Blades of the Diego Powered Dissector and Drill System ([K020594](/device/K020594.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to suggest community and support. The logo is presented in black and white. 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 {2}------------------------------------------------ ### 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 ● {3}------------------------------------------------ ## 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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, | | | {5}------------------------------------------------ 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. | {6}------------------------------------------------ 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 | #### Predicate and Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades device comparison chart. Table 1: --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/NLY/K142022](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/NLY/K142022) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com