Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and functional aspects of a fluid manifold for a waste management system, with no mention of AI or ML.

Therapeutic

No.
The device is an accessory for a waste management system that collects surgical fluid waste and smoke, and it is non-patient contacting. It does not directly provide therapy to a patient.

Diagnostic

No

The device description clearly states its purpose is to "collect and dispose of surgical fluid waste and to collect smoke generated by electrocautery or laser devices," and that it provides a "fluid path from the suction tubing lines... to the receiving collection canisters." This indicates a waste management function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a disposable hardware component (manifold) that provides a fluid path, and the performance studies focus on physical attributes like structural integrity, leakage, and cleaning efficacy, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to collect and dispose of surgical fluid waste and smoke. This is a waste management function, not a diagnostic test performed on a sample taken from the human body.
Device Description: The device description states it provides a fluid path for waste and is non-patient contacting. IVDs typically interact with patient samples (blood, urine, tissue, etc.) to provide diagnostic information.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect markers, or provide any information for diagnosing a disease or condition.

The device is an accessory for a surgical waste management system, which is a medical device, but not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 electrocantery or laser devices.

Product codes (comma separated list FDA assigned to the subject device)

JCX

Device Description

The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are non-patient contacting, non-sterile, disposable devices that provide a fluid path from the suction tubing lines of a Stryker Neptune 2 Waste Management System to the receiving collection canisters of this system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room, pathology laboratories, surgical centers and doctor's offices

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 Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds have been evaluated based on the following tests:
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 carbohydrate); Soil characterization. Intermediate level disinfection.

The results of the nonclinical tests performed demonstrated that the Medline ReNewal Reprocessed Stryker Neptune 2 Manifold is as safe, as effective, and performs as well or better than the legally marketed predicate Stryker Neptune 2 Manifold. Based on these results and a comparison of the indications for use, intended use and technological characteristics, the two devices are substantially equivalent.

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.

K132671

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

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile forming the shape of a bird or wing.

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

1

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/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 (800) 638-2041 or (301) 796-7100 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

2

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)

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

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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/
Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave
Redmond, OR 97756 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, Quality Assurance and Regulatory Affairs
P: 541-516-4180
F: 541-923-3375
E: bpanteleon@medline.com |
| Date Prepared | Aug 2, 2017 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Stryker Neptune 2
Manifolds
Common Name: Portable suction and smoke evacuation device
(component) |
| Classification | Classification: Class II
Regulation Number: 878.4780
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
Device | K132671 - Stryker Neptune 2 Waste Management System Manifolds |
| Device
Description | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are non-
patient contacting, non-sterile, disposable devices that provide a fluid path
from the suction tubing lines of a Stryker Neptune 2 Waste Management
System to the receiving collection canisters of this system. |
| Statement of
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. |

4

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
Characteristics | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are
available in the following configurations: Single-Port Manifold, Four-Port
Manifold and Four-Port Manifold with Specimen Collection. All three design
configurations attach to the receptacle canister of a Stryker Neptune 2
Waste Management System rover. The manifolds then act as conduits
between the system's suction tubing lines, which connect to the manifold
port(s), and the system's 4L and 20L receiving canisters. The proposed
device is a reprocessed version of the predicate device manifolds. | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Testing | The functional characteristics of the Medline ReNewal Reprocessed Stryker
Neptune 2 Manifolds have been evaluated based on the following tests:
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
carbohydrate); Soil characterization. Intermediate level disinfection | |
| | Conclusion | The results of the nonclinical tests performed demonstrated that the
Medline ReNewal Reprocessed Stryker Neptune 2 Manifold is as safe, as
effective, and performs as well or better than the legally marketed predicate
Stryker Neptune 2 Manifold. Based on these results and a comparison of
the indications for use, intended use and technological characteristics, the
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
Characteristi
CS	Stryker Neptune 2 Waste
Management System
Manifolds	Medline ReNewal
Reprocessed
Stryker Neptune 2
Manifolds	Same device;
original and
reprocessed
510(k)
Number	K132671	TBD	N/A
Product Name	Stryker Neptune 2 Waste
Management System
Manifolds	Medline ReNewal
Reprocessed
Stryker Neptune 2 Manifolds	N/A
Intended Use	The Stryker Neptune 2 Waste
Management System
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.	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.	Same
Technological
Characteristics	The Stryker Neptune 2 Waste
Management System
Manifolds are available in the
following configurations:
Single-Port Manifold, Four-
Port Manifold and Four-Port
Manifold with Specimen
Collection. All three of these
configurations are designed
to attach to the receptacle
canister of a Stryker Neptune
2 Waste Management
System rover. The manifolds
then act as conduits between
the system's suction tubing
lines, which connect to the
manifold port(s), and the
system's 4L and 20L	The Medline ReNewal
Reprocessed Stryker
Neptune 2 Manifolds are
available in the following
configurations: Single-Port
Manifold, Four-Port Manifold
and Four-Port Manifold with
Specimen Collection. All three
of these configurations are
designed to attach to the
receptacle canister of a
Stryker Neptune 2 Waste
Management System rover.
The manifolds then act as
conduits between the
system's suction tubing lines,
which connect to the manifold
port(s), and the system's 4L
and 20L	Same

Table 1: Predicate and Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds device

comparison chart.