(444 days)
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.
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.
The provided text is a 510(k) premarket notification summary for the Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds. This document describes a reprocessed medical device, which is a physical product, not a software or AI-based device.
Therefore, the concepts of acceptance criteria, test sets, training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document. The study described in the document pertains to the physical and functional performance of the reprocessed surgical manifolds and their equivalence to new manifolds.
The document discusses "Performance Testing" for the reprocessed manifolds, which includes:
- Functional performance studies: simulated use and artificial soiling; structural integrity; installation and removal; vacuum/sealing; leakage (backflow prevention valve, drip-reduction valve, mating components); specimen collection; and performance post-accelerated aging.
- Cleaning: visual inspection; cleaning efficacy (residual protein and residual carbohydrate); soil characterization.
- Intermediate level disinfection.
The conclusion is that these nonclinical tests demonstrated the reprocessed manifold to be "as safe, as effective, and performs as well or better than the legally marketed predicate Stryker Neptune 2 Manifold." This establishes substantial equivalence to the predicate device.
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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 (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
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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)
| 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 AveRedmond, OR 97756 |
|---|---|
| Contact Name | Brandi PanteleonDirector, Quality Assurance and Regulatory AffairsP: 541-516-4180F: 541-923-3375E: bpanteleon@medline.com |
| Date Prepared | Aug 2, 2017 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Stryker Neptune 2ManifoldsCommon Name: Portable suction and smoke evacuation device(component) |
| Classification | Classification: Class IIRegulation Number: 878.4780Product 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. |
| PredicateDevice | K132671 - Stryker Neptune 2 Waste Management System Manifolds |
| DeviceDescription | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are non-patient contacting, non-sterile, disposable devices that provide a fluid pathfrom the suction tubing lines of a Stryker Neptune 2 Waste ManagementSystem to the receiving collection canisters of this system. |
| Statement ofIntended Use | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds areaccessories for use with the Stryker Neptune 2 Waste ManagementSystem, specifically the rover. The Neptune 2 Waste Management systemis intended to be used in the operating room, pathology laboratories,surgical centers and doctor's offices to collect and dispose of surgical fluidwaste 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.
| TechnologicalCharacteristics | The Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds areavailable in the following configurations: Single-Port Manifold, Four-PortManifold and Four-Port Manifold with Specimen Collection. All three designconfigurations attach to the receptacle canister of a Stryker Neptune 2Waste Management System rover. The manifolds then act as conduitsbetween the system's suction tubing lines, which connect to the manifoldport(s), and the system's 4L and 20L receiving canisters. The proposeddevice is a reprocessed version of the predicate device manifolds. | |
|---|---|---|
| PerformanceTesting | The functional characteristics of the Medline ReNewal Reprocessed StrykerNeptune 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 residualcarbohydrate); Soil characterization. Intermediate level disinfection | |
| Conclusion | The results of the nonclinical tests performed demonstrated that theMedline ReNewal Reprocessed Stryker Neptune 2 Manifold is as safe, aseffective, and performs as well or better than the legally marketed predicateStryker Neptune 2 Manifold. Based on these results and a comparison ofthe indications for use, intended use and technological characteristics, thetwo 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 | |
|---|---|---|---|
| DeviceCharacteristiCS | Stryker Neptune 2 WasteManagement SystemManifolds | Medline ReNewalReprocessedStryker Neptune 2Manifolds | Same device;original andreprocessed |
| 510(k)Number | K132671 | TBD | N/A |
| Product Name | Stryker Neptune 2 WasteManagement SystemManifolds | Medline ReNewalReprocessedStryker Neptune 2 Manifolds | N/A |
| Intended Use | The Stryker Neptune 2 WasteManagement SystemManifolds are accessories foruse with the Stryker Neptune2 Waste ManagementSystem, specifically the rover.The Neptune 2 WasteManagement system isintended to be used in theoperating room, pathologylaboratories, surgical centersand doctor's offices to collectand dispose of surgical fluidwaste and to collect smokegenerated by electrocauteryor laser devices. | The Medline ReNewalReprocessed StrykerNeptune 2 Manifolds areaccessories for use with theStryker Neptune 2 WasteManagement System,specifically the rover.The Neptune 2 WasteManagement system isintended to be used in theoperating room, pathologylaboratories, surgical centersand doctor's offices to collectand dispose of surgical fluidwaste and to collect smokegenerated by electrocauteryor laser devices. | Same |
| TechnologicalCharacteristics | The Stryker Neptune 2 WasteManagement SystemManifolds are available in thefollowing configurations:Single-Port Manifold, Four-Port Manifold and Four-PortManifold with SpecimenCollection. All three of theseconfigurations are designedto attach to the receptaclecanister of a Stryker Neptune2 Waste ManagementSystem rover. The manifoldsthen act as conduits betweenthe system's suction tubinglines, which connect to themanifold port(s), and thesystem's 4L and 20L | The Medline ReNewalReprocessed StrykerNeptune 2 Manifolds areavailable in the followingconfigurations: Single-PortManifold, Four-Port Manifoldand Four-Port Manifold withSpecimen Collection. All threeof these configurations aredesigned to attach to thereceptacle canister of aStryker Neptune 2 WasteManagement System rover.The manifolds then act asconduits between thesystem's suction tubing lines,which connect to the manifoldport(s), and the system's 4Land 20L | Same |
Table 1: Predicate and Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds device
comparison chart.
§ 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.