Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

• K Number: K172608
• Device Name: Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
• Manufacturer: Surgical Instrument Service and Savings Inc
• Date Cleared: 2017-10-18 ( 48 days)
• Product Code: NUJ
• Regulation Number: 878.4400

Intended Use

The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist.

Device Description

The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are single-use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to control ablation, coagulation, and the power setting. The devices are connected to the appropriate generator by a connector cable. The generators and the foot switches are not included in the scope of this project, and they will not be reprocessed.

Predicate Devices

K041810

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a reprocessed electrosurgical probe and its functional testing, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is used for resection, ablation of soft tissue, and hemostasis of blood vessels, which are all therapeutic procedures.

Diagnostic

No

Explanation: The device is described as a radio frequency probe used for resection, ablation of soft tissue, and hemostasis of blood vessels in electrosurgical procedures. Its function is to perform surgical actions, not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical probe with a handle, finger switches, a suction line, and a connector cable. It also mentions being connected to a generator and foot switches, all of which are hardware components. The performance studies also focus on physical and electrical characteristics of the probe.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device Function: The description clearly states that the Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a surgical tool used during procedures (arthroscopic surgery) for resection, ablation, and hemostasis of soft tissue and blood vessels within the patient's body.
• No Specimen Analysis: There is no mention of collecting or analyzing specimens from the body. The device directly interacts with tissue during surgery.

Therefore, based on the provided information, the device is an electrosurgical probe used in surgical procedures, 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 SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist.

Product codes

NUJ

Device Description

The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are single-use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to control ablation, coagulation, and the power setting. The devices are connected to the appropriate generator by a connector cable. The generators and the foot switches are not included in the scope of this project, and they will not be reprocessed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

knee, shoulder, ankle, hip, elbow, and wrist

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

The functional characteristics of the proposed Medline ReNewal Reprocessed Stryker SERFAS Energy Probe have been evaluated and found to be equivalent to the Stryker SERFAS Energy Probe predicate devices based on the following tests: sterilization validation; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; electrical testing electromagnetic compatibility (in accordance with IEC 60601-1-2); electrical safety (in accordance with IEC 60601-1 and IEC 60601-2-2); and basic safety (in accordance with IEC 60601-1 and IEC 60601-2-2) performance qualification: simulated use; critical function bending equivalence test; critical function suction equivalence test; critical function thermal tissue damage equivalence test; critical function drop equivalence test; critical function device equivalence integrity; and product stability; cleaning; protein, and hemoglobin.

Key Metrics

Not Found

Predicate Device(s)

K041810

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 18, 2017

Surgical Instrument Service and Savings (dba Medline ReNewal) Ms. Stephanie Boyle Mays Regulatory Specialist, Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K172608

Trade/Device Name: Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (Models:279-351-100, 279-351-230, 279-351-250, 279-351-300,279-351-400, and 279-401-100) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: August 30, 2017 Received: August 31, 2017

Dear Ms. Mays:

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 of medical device-related adverse events) (21 CFR 803); good

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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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S3

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

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Indications for Use

510(k) Number (if known) K172608

Device Name

Medline ReNewal Reprocessed Stryker SERFAS Energy Probes (models: 279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100)

Indications for Use (Describe)

The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist.

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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| Device
Model | Device Name | Original
Manufacturer |
|-----------------|--------------------------------------------------------|--------------------------|
| 279-351-100 | 90-S SERFAS Energy Suction Probe
3.5 mm | Stryker |
| 279-351-230 | 30-S SERFAS Energy Suction Probe
3.5 mm | Stryker |
| 279-351-250 | 50-S SERFAS Energy Suction Probe
3.5 mm | Stryker |
| 279-351-300 | Super 90-S SERFAS Energy Suction Probe
3.5 mm | Stryker |
| 279-351-400 | 90-S Accelerator SERFAS Energy Suction Probe
3.5 mm | Stryker |
| 279-401-100 | 90-S MAX SERFAS Energy Suction Probe
4.0 mm | Stryker |

Reprocessed Single-Use Device Models Included in Clearance:

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Image /page/4/Picture/1 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue symbol to the left of it. To the right of "Medline" is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in blue.

510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

| Submitter/
Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave.
Redmond, OR 97756 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | August 30, 2017 |
| Contact
Name/Prepared
by | Stephanie Boyle Mays
Regulatory Affairs Specialist, Regulatory Affairs
P: 541-516-4205/F: 541-923-3375
E: [e-mail] |
| Device Name
and
Classification | Propriety/Trade Name:
Medline ReNewal Reprocessed Stryker
SERFAS Energy Probes, models: 279-351-100,
279-351-230, 279-351-250, 279-351-300, 279-
351-400, and 279-401-100
Common Name:
Electrosurgical cutting and coagulation device
and accessories
Classification:
Class II
Regulation Number:
21 CFR § 878.4400
Product Code:
NUJ
Panel:
General & Plastic Surgery |
| 510(k) Number | K041810 |
| | Propriety/Trade Name:
Stryker SERFAS Energy Probes, models: 279-
351-100, 279-351-230, 279-351-250, 279-351-
300, 279-351-400, and 279-401-100 |
| Predicate
Device and
Classification | Common Name:
Electrosurgical cutting and coagulation device
and accessories
Classification:
Class II
Regulation Number:
21 CFR § 878.4400
Product Code:
GEI
Panel:
General & Plastic Surgery
Manufacturer:
Stryker Endoscopy, 5900 Optical Ct., San Jose,
CA 95138 |
| Intended Use | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a
disposable, radio frequency probe used in electrosurgical procedures for
resection, ablation, and coagulation of soft tissue, as well as the
hemostasis of blood vessels in patients undergoing arthroscopic surgery of
the knee, shoulder, ankle, hip, elbow, and wrist. |
| Product
Description | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are
single-use devices that have been cleaned, disinfected, inspected,
refurbished, tested, packaged, labeled, and sterilized. All models can be
operated with integrated finger switches on the device handle to control
ablation, coagulation and power level. Each model also has a suction line
that removes tissue and fluids from the surgical site. In addition, the models
can be operated with foot switches, which offer another mode with which to |

5

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

| Device

Characteristics	Predicate	Proposed	Comparison
510(k)	Stryker SERFAS Energy
Probes	Medline ReNewal
Reprocessed Stryker
SERFAS Energy Probes	As Stated
510(k)	K041810	TBD	Not applicable
Model Numbers	• 279-351-100
• 279-351-230
• 279-351-250
• 279-351-300
• 279-351-400
• 279-401-100	• 279-351-100
• 279-351-230
• 279-351-250
• 279-351-300
• 279-351-400
• 279-401-100	Same
Intended Use	The SERFAS Energy
Probe is a disposable,
radio frequency probe used
in electrosurgical
procedures for resection,
ablation, and coagulation
of soft tissue, as well as
the hemostasis of blood
vessels in patients
undergoing arthroscopic
surgery of the knee,
shoulder, ankle, hip, elbow,
and wrist.
The probe includes an
energy-transferring cable
as well as several different
tip configurations and
suction probes which are
capable of providing
simultaneous fluid
aspirations	The Medline ReNewal
Reprocessed SERFAS
Energy Probe is a
disposable, radio
frequency probe used in
electrosurgical procedures
for resection, ablation, and
coagulation of soft tissue,
as well as the hemostasis
of blood vessels in patients
undergoing arthroscopic
surgery of the knee,
shoulder, ankle, hip, elbow,
and wrist.
The probe includes an
energy-transferring cable
as well as several different
tip configurations and
suction probes which are
capable of providing
simultaneous fluid
aspirations.	Same
510(k) Substantial Equivalence Chart (concluded)
	Predicate	Proposed	Comparison
Device
Characteristics	Stryker SERFAS Energy
Probes	Medline ReNewal
Reprocessed Stryker
SERFAS Energy Probes	As Stated
Product
Description	The Stryker SERFAS
Energy Probes are single-
use devices. All models
can be operated with
integrated finger switches
on the device handle to
control ablation,
coagulation and power
level. Each model also has
a suction line that removes
tissue and fluids from the
surgical site. In addition,
the models can be
operated with foot
switches, which offer
another mode with which to
control ablation,
coagulation, and the power
setting. The devices are
connected to the
appropriate generator by a
connector cable.	The Medline ReNewal
Reprocessed Stryker
SERFAS Energy Probes
are single-use devices that
have been cleaned,
disinfected, inspected,
refurbished, tested,
packaged, labeled, and
sterilized. All models can
be operated with integrated
finger switches on the
device handle to control
ablation, coagulation and
power level. Each model
also has a suction line that
removes tissue and fluids
from the surgical site. In
addition, the models can
be operated with foot
switches, which offer
another mode with which to
control ablation,
coagulation, and the power
setting. The devices are
connected to the
appropriate generator by a
connector cable. The
generators and the foot
switches are not included
in the scope of this project,
and they will not be
reprocessed.	As stated
Power Platform	Stryker SERFAS
● Energy System
Stryker Crossfire
● System	Stryker SERFAS
● Energy System
Stryker Crossfire
● System	Same
Technological
Characteristics	The technological characteristics and the fundamental
scientific technology of the subject devices are identical
to the predicate device. The proposed devices are a
reprocessed version of the predicate K041810 Stryker
SERFAS Energy Probes. The predicate devices were
used to support intended use, technological
characteristics, and functional performance
specifications.		Same

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Image /page/6/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 it.

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Image /page/7/Picture/1 description: The image is a 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. The logo is clean and professional.

| Performance
Testing | The functional characteristics of the proposed Medline ReNewal
Reprocessed Stryker SERFAS Energy Probe have been evaluated and
found to be equivalent to the Stryker SERFAS Energy Probe predicate
devices based on the following tests: |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | sterilization validation; |
| | biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; |
| | electrical testing electromagnetic compatibility (in accordance with IEC 60601-1-2); electrical safety (in accordance with IEC 60601-1 and IEC 60601-2-2); and basic safety (in accordance with IEC 60601-1 and IEC 60601-2-2) |
| | performance qualification: simulated use; critical function bending equivalence test; critical function suction equivalence test; critical function thermal tissue damage equivalence test; critical function drop equivalence test; critical function device equivalence integrity; and product stability |
| | cleaning; protein, and hemoglobin. |
| | Conclusion |