(142 days)
Not Found
No
The 510(k) summary describes a reprocessed surgical instrument and does not mention any AI or ML capabilities. The performance studies focus on the physical and functional characteristics of the device.
No
The device is described as an endoscopic instrument used to facilitate grasping, mobilization, and dissection of tissue. While these are surgical actions performed by a medical professional, the device itself is not described as directly treating a disease or condition in a therapeutic manner such as drug delivery, radiation, or stimulation. It is a tool for surgical procedures.
No
Explanation: The device is described as an endoscopic instrument used to facilitate grasping, mobilization, and dissection of tissue, indicating it is an interventional or surgical tool, not a diagnostic one. Its stated intended use relates to manipulating tissue rather than identifying or characterizing a medical condition.
No
The device description and performance studies clearly indicate a physical, reprocessed surgical instrument with extensive hardware testing (functional, electrical safety, sterilization, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in "minimally invasive procedures to facilitate grasping, mobilization, dissection of tissue." This is a description of a surgical instrument used on the body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details the reprocessing of a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that category.
N/A
Intended Use / 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 of tissue.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected packaged, labeled, and sterilize for an additional clinical use.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The functional characteristics of the subject devices have been evaluated and found to be equivalent to the predicate devices based on the following tests:
• Simulated use; grasping/pulling force;
• Cutting effectiveness/functionality;
• Device integrity;
• Coagulation evaluation;
• Cleaning;
• Protein, carbohydrates, visual inspection (under magnification)
Biocompatibility:
• Cytotoxicity, sensitization, irritation, acute systemic toxicity and pyrogenicity
• 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.
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.
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
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by a flowing line that resembles a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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
1
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 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 | |
| Instruments – Curved Dissector | Ethicon Endo-Surgery | |
| 5DCS | Endopath 5 mm Diameter Endoscopic | |
| 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Acting Director, Quality Assurance/Regulatory Affairs
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com |
| Date Prepared | August 13, 2015 |
| Device Names | Proprietary Name: Reprocessed Medline ReNewal Endopath 5-mm
Diameter Endoscopic Instruments |
| Classification | 878: General and plastic surgery devices
21 CFR §878.4400 - electrosurgical cutting and coagulation device and
accessories. Class II, product code NUJ |
| Predicate
Device | K984240 Endopath Endoscopic Instruments manufactured by Ethicon
Endo-Surgery, Inc. |
| Device
Description | Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm
Diameter Endoscopic Instruments (originally manufactured by Ethicon
Endo-Surgery) are cleaned, refurbished, tested, inspected packaged,
labeled, and sterilize for an additional clinical use. |
| Statement of
Intended 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. |
| Technological
Characteristics | The technological characteristics and the scientific technology of the
subject devices are identical to the predicate devices listed in this
submission. The proposed devices are a reprocessed version of the
predicate devices. |
| Performance
Testing | The functional characteristics of the subject devices have been evaluated
and found to be equivalent to the predicate devices based on the following
tests:
• Simulated use; grasping/pulling force;
• Cutting effectiveness/functionality;
• Device integrity;
• Coagulation evaluation;
• Cleaning;
• Protein, carbohydrates, visual inspection (under magnification)
Biocompatibility:
• Cytotoxicity, sensitization, irritation, acute systemic toxicity and
pyrogenicity
• 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.
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.