Medline ReNewal Reprocessed Endopath Endoscopic Instruments

K152313 · Surgical Instrument Services and Savings, Inc. · NUJ · Jan 6, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152313
• Device Name: Medline ReNewal Reprocessed Endopath Endoscopic Instruments
• Applicant: Surgical Instrument Services and Savings, Inc.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Jan 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

Device Story

Reprocessed single-use endoscopic instruments (curved dissector, curved scissors); originally manufactured by Ethicon Endo-Surgery. Medline ReNewal cleans, refurbishes, tests, inspects, packages, labels, and sterilizes previously used devices for additional clinical use. Used in minimally invasive surgery; operated by surgeons. Devices facilitate tissue grasping, mobilization, dissection, and transection. Reprocessing restores functional integrity equivalent to original device.

Clinical Evidence

Bench testing only. Performance evaluation included simulated use, grasping/pulling force, cutting effectiveness, device integrity, coagulation evaluation, cleaning validation, and biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity). Electrical safety verified per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Sterilization validation and product stability testing performed.

Technological Characteristics

Reprocessed 5mm diameter endoscopic instruments. Electrosurgical cutting and coagulation capability. Electrical safety per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Sterilization validated. Technological characteristics identical to predicate.

Indications for Use

Indicated for use in minimally invasive surgical procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Endopath Endoscopic Instruments (K984240)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2016

Surgical Instrument Services and Savings Incorporated Ms. Brandi Panteleon Acting Director, Quality Assurance and Regulatory Affairs 2747 Southwest 6th Street Redmond, Oregon 97756

Re: K152313

Trade/Device Name: Medline Renewal Reprocessed Endopath Endoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: December 8, 2015 Received: December 9, 2015

Dear Ms. Panteleon:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Reprocessed Single-Use Device Models Included in Clearance:

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| Device Model | Device Name | Original Manufacturer |
|--------------|---------------------------------------------------------------------|-----------------------|
| 5DCD | Endopath 5 mm Diameter Endoscopic<br>Instruments – Curved Dissector | Ethicon Endo-Surgery |
| 5DCS | Endopath 5 mm Diameter Endoscopic<br>Instruments - Curved Scissors | Ethicon Endo-Surgery |

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## Indications for Use

510(k) Number (if known) K152313

#### Device Name

Medline ReNewal Reprocessed Endopath Endoscopic Instruments

#### Indications for Use (Describe)

Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection of tissue.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in black font with a blue star to the left of the word. To the right of the word "Medline" is the word "Renewal" in green and blue font, with the words "Full Circle Reprocessing" in a smaller font below the word "Renewal".

# 5.0 510(k) Summary)

| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon<br>Acting Director, Quality Assurance/Regulatory Affairs<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] |
| Date Prepared | August 13, 2015 |
| Device Names | Proprietary Name: Reprocessed Medline ReNewal Endopath 5-mm<br>Diameter Endoscopic Instruments |
| Classification | 878: General and plastic surgery devices<br>21 CFR §878.4400 - electrosurgical cutting and coagulation device and<br>accessories. Class II, product code NUJ |
| Predicate<br>Device | K984240 Endopath Endoscopic Instruments manufactured by Ethicon<br>Endo-Surgery, Inc. |
| Device<br>Description | Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm<br>Diameter Endoscopic Instruments (originally manufactured by Ethicon<br>Endo-Surgery) are cleaned, refurbished, tested, inspected packaged,<br>labeled, and sterilize for an additional clinical use. |
| Statement of<br>Intended Use | Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm<br>Diameter Endoscopic Instruments have application in a variety of minimally<br>invasive procedures to facilitate grasping, mobilization, dissection and<br>transection of tissue. |
| Technological<br>Characteristics | The technological characteristics and the scientific technology of the<br>subject devices are identical to the predicate devices listed in this<br>submission. The proposed devices are a reprocessed version of the<br>predicate devices. |
| Performance<br>Testing | The functional characteristics of the subject devices have been evaluated<br>and found to be equivalent to the predicate devices based on the following<br>tests:<br>• Simulated use; grasping/pulling force;<br>• Cutting effectiveness/functionality;<br>• Device integrity;<br>• Coagulation evaluation;<br>• Cleaning;<br>• Protein, carbohydrates, visual inspection (under magnification)<br>Biocompatibility:<br>• Cytotoxicity, sensitization, irritation, acute systemic toxicity and<br>pyrogenicity<br>• Functional performance validation; |
| • | Electrical safety in accordance with IEC 60601-1; |
| • | Electrical safety in accordance with IEC 60601-1-2; |
| • | Electrical safety in accordance with IEC 60601-2-2; |
| • | Thermal analysis characterization; |
| • | Sterilization validation; and |
| • | Product stability. |
| Conclusion | Based on comparisons of the indications for use, intended use.<br>Technological characteristics and performance data to the predicate devices, Reprocessed Medline ReNewal Endopath 5-mm Diameter Endoscopic Instruments are substantially equivalent to the predicate devices. |

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Image /page/5/Picture/0 description: The image contains the logos for Medline and ReNewal. The Medline logo is on the left and consists of the word "MEDLINE" in a sans-serif font with a stylized blue symbol next to it. To the right of the Medline logo is the ReNewal logo, with the word "ReNewal" in a bold, two-tone green and blue font. Below "ReNewal" is the text "Full Circle Reprocessing" in a smaller, sans-serif font.