Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

K161358 · Surgical Instrument Service and Savings, Inc. · JCX · Aug 3, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161358
• Device Name: Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Aug 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended Use

The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are accessories for use with the Stryker Neptune 2 Waste Management System, specifically the rover. The Neptune 2 Waste Management system is intended to be used in the operating room, pathology laboratories, surgical centers and doctor's offices to collect and dispose of surgical fluid waste and to collect smoke generated by electrocautery or laser devices.

Device Story

Reprocessed manifold accessory for Stryker Neptune 2 Waste Management System; provides fluid path between suction tubing and system collection canisters (4L/20L). Configurations include single-port, four-port, and four-port with specimen collection. Used in ORs, pathology labs, surgical centers, and clinics. Acts as conduit for surgical fluid and smoke; prevents backflow and drips via integrated valves. Reprocessed to restore functionality of original predicate device; maintains identical mechanical interface with Neptune 2 rover canisters.

Clinical Evidence

Bench testing only. Evaluated via functional performance studies (simulated use, artificial soiling, structural integrity, installation/removal, vacuum/sealing, backflow/drip-reduction valve leakage, specimen collection, accelerated aging) and cleaning/disinfection validation (visual inspection, residual protein/carbohydrate, soil characterization).

Technological Characteristics

Non-patient contacting, non-sterile, disposable plastic manifold. Configurations: Single-Port, Four-Port, Four-Port with Specimen Collection. Interfaces with Stryker Neptune 2 rover canisters. Functions as fluid/smoke conduit. Includes backflow prevention and drip-reduction valves. Reprocessed via cleaning and intermediate-level disinfection.

Indications for Use

Indicated for use in operating rooms, pathology labs, surgical centers, and doctor's offices as an accessory to the Stryker Neptune 2 Waste Management System for the collection/disposal of surgical fluid waste and collection of smoke from electrocautery or laser devices.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Stryker Neptune 2 Waste Management System Manifolds (K132671)

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

August 3, 2017

Surgical Instrument Service and Savings Inc Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 Sw 6th St. Redmond, Oregon 97756

Re: K161358

Trade/Device Name: Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: July 27, 2017 Received: July 28, 2017

Dear Brandi 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

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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 [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,

## Michael J. Ryan -S

for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K161358

Device Name

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

Indications for Use (Describe)

The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are accessories for use with the Stryker Neptune 2 Waste Management System, specifically the rover.

The Neptune 2 Waste Management system is intended to be used in the operating room, pathology laboratories, surgical centers and doctor's offices to collect and dispose of surgical fluid waste and to collect smoke generated by electrocantery or laser devices.

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

| <div> <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------|
| <div> <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/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 words "Full Circle Reprocessing" are below the Renewal logo. The Medline logo is blue and features a stylized star.

# K161358 Summary

| Submitter/<br>Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)<br>1500 NE Hemlock Ave<br>Redmond, OR 97756 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon<br>Director, Quality Assurance and Regulatory Affairs<br>P: 541-516-4180<br>F: 541-923-3375<br>E: [e-mail] |
| Date Prepared | Aug 2, 2017 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Stryker Neptune 2<br>Manifolds<br>Common Name: Portable suction and smoke evacuation device<br>(component) |
| Classification | Classification: Class II<br>Regulation Number: 878.4780<br>Product Code: JCX |
| Device Models | 0702-025-000 Neptune 2 Single-Port Manifold; 0702-020-000 Neptune 2 4-Port Manifold; and 0702-020-001 Neptune 2 Specimen Collection 4-Port Manifold. |
| Predicate<br>Device | K132671 - Stryker Neptune 2 Waste Management System Manifolds |
| Device<br>Description | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are non-<br>patient contacting, non-sterile, disposable devices that provide a fluid path<br>from the suction tubing lines of a Stryker Neptune 2 Waste Management<br>System to the receiving collection canisters of this system. |
| Statement of<br>Intended Use | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are<br>accessories for use with the Stryker Neptune 2 Waste Management<br>System, specifically the rover. The Neptune 2 Waste Management system<br>is intended to be used in the operating room, pathology laboratories,<br>surgical centers and doctor's offices to collect and dispose of surgical fluid<br>waste and to collect smoke generated by electrocautery or laser devices. |

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Image /page/4/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The logo features the word "MEDLINE" in blue, with a blue star-like symbol to the right of it. To the right of that is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in blue underneath it. The logo is clean and professional, and it conveys a sense of renewal and sustainability.

| Technological<br>Characteristics | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are<br>available in the following configurations: Single-Port Manifold, Four-Port<br>Manifold and Four-Port Manifold with Specimen Collection. All three design<br>configurations attach to the receptacle canister of a Stryker Neptune 2<br>Waste Management System rover. The manifolds then act as conduits<br>between the system's suction tubing lines, which connect to the manifold<br>port(s), and the system's 4L and 20L receiving canisters. The proposed<br>device is a reprocessed version of the predicate device manifolds. | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing | The functional characteristics of the Medline ReNewal Reprocessed Stryker<br>Neptune 2 Manifolds have been evaluated based on the following tests:<br>Functional performance studies: simulated use and artificial soiling; structural integrity; installation and removal; vacuum/sealing; leakage – backflow prevention valve (use); leakage – backflow prevention valve (disposal); leakage – drip-reduction valve; leakage – mating components; specimen collection; performance studies post accelerated aging. Cleaning: visual inspection; cleaning efficacy (residual protein and residual<br>carbohydrate); Soil characterization. Intermediate level disinfection | |
| | Conclusion | The results of the nonclinical tests performed demonstrated that the<br>Medline ReNewal Reprocessed Stryker Neptune 2 Manifold is as safe, as<br>effective, and performs as well or better than the legally marketed predicate<br>Stryker Neptune 2 Manifold. Based on these results and a comparison of<br>the indications for use, intended use and technological characteristics, the<br>two devices are substantially equivalent. |

Continued

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Image /page/5/Picture/1 description: The image shows the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are in smaller blue letters below the Renewal logo.

| | Predicate | Proposed | Comparison |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Device<br>Characteristi<br>CS | Stryker Neptune 2 Waste<br>Management System<br>Manifolds | Medline ReNewal<br>Reprocessed<br>Stryker Neptune 2<br>Manifolds | Same device;<br>original and<br>reprocessed |
| 510(k)<br>Number | K132671 | TBD | N/A |
| Product Name | Stryker Neptune 2 Waste<br>Management System<br>Manifolds | Medline ReNewal<br>Reprocessed<br>Stryker Neptune 2 Manifolds | N/A |
| Intended Use | The Stryker Neptune 2 Waste<br>Management System<br>Manifolds are accessories for<br>use with the Stryker Neptune<br>2 Waste Management<br>System, specifically the rover.<br>The Neptune 2 Waste<br>Management system is<br>intended to be used in the<br>operating room, pathology<br>laboratories, surgical centers<br>and doctor's offices to collect<br>and dispose of surgical fluid<br>waste and to collect smoke<br>generated by electrocautery<br>or laser devices. | The Medline ReNewal<br>Reprocessed Stryker<br>Neptune 2 Manifolds are<br>accessories for use with the<br>Stryker Neptune 2 Waste<br>Management System,<br>specifically the rover.<br>The Neptune 2 Waste<br>Management system is<br>intended to be used in the<br>operating room, pathology<br>laboratories, surgical centers<br>and doctor's offices to collect<br>and dispose of surgical fluid<br>waste and to collect smoke<br>generated by electrocautery<br>or laser devices. | Same |
| Technological<br>Characteristics | The Stryker Neptune 2 Waste<br>Management System<br>Manifolds are available in the<br>following configurations:<br>Single-Port Manifold, Four-<br>Port Manifold and Four-Port<br>Manifold with Specimen<br>Collection. All three of these<br>configurations are designed<br>to attach to the receptacle<br>canister of a Stryker Neptune<br>2 Waste Management<br>System rover. The manifolds<br>then act as conduits between<br>the system's suction tubing<br>lines, which connect to the<br>manifold port(s), and the<br>system's 4L and 20L | The Medline ReNewal<br>Reprocessed Stryker<br>Neptune 2 Manifolds are<br>available in the following<br>configurations: Single-Port<br>Manifold, Four-Port Manifold<br>and Four-Port Manifold with<br>Specimen Collection. All three<br>of these configurations are<br>designed to attach to the<br>receptacle canister of a<br>Stryker Neptune 2 Waste<br>Management System rover.<br>The manifolds then act as<br>conduits between the<br>system's suction tubing lines,<br>which connect to the manifold<br>port(s), and the system's 4L<br>and 20L | Same |

### Table 1: Predicate and Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds device
comparison chart.