(192 days)
Not Found
No
The summary describes a mechanical suture passing device and does not mention any AI or ML components or functionalities.
No
The device is a surgical instrument used to pass sutures through soft tissues during endoscopic/laparoscopic surgery. It is a tool for performing a medical procedure, not a device that directly treats or prevents a disease or condition itself.
No
The device is a surgical instrument designed to pass suture through soft tissues, not to diagnose a condition or disease. The description of its intended use and performance studies focuses on its mechanical function and safety, without mention of diagnostic capabilities.
No
The device description clearly states it is a "hand-held suture grasping device" and describes physical components and testing related to hardware (simulated use, device integrity, cleaning, biocompatibility, sterilization validation, product stability). This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for passing suture through soft tissues during endoscopic/laparoscopic surgery. This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description confirms it's a "hand-held suture grasping device" used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided describes a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
Product codes
NLM
Device Description
The Medline ReNewal Reprocessed Carter-Thomason Suture Passer Set (models CTI-512N, CTI-1015N, PG-15S, and PG-5/10) is a sterile, single-case use, hand-held suture grasping device that is designed to pass suture through soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues of the body
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 proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests:
- simulated use;
- device integrity;
- cleaning:
- protein, carbohydrates and hemoglobin;
- biocompatibility:
- cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity;
- performance qualification;
- sterilization validation; and
- product stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182828
Device Name
Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set
Indications for Use (Describe)
The Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
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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1
| OEM Device
| Modela | Device Name | OEM |
|---|---|---|
| CTI-512N | Carter Thomason CloseSure System | |
| (Carter Thomason Suture Passer, 5-mm | ||
| Pilot Guide, 10/12-mm Pilot Guide) | Louisville | |
| Laboratories, Inc. | ||
| CTI-1015N | Carter Thomason CloseSure System | |
| (Carter Thomason Suture Passer, | ||
| 10/12-mm Pilot Guide, 115-mm Pilot | ||
| Guide) | Louisville | |
| Laboratories, Inc. | ||
| PG-15S | 15-mm Pilot Guide | Louisville |
| Laboratories, Inc. | ||
| PG-5/10 | 5-mm Pilot Guide, 10/12 mm Pilot Guide | Louisville |
| Laboratories, Inc. | ||
| a OEM = original equipment manufacturer. |
K182588 Reprocessed Carter-Thomason CloseSure Devices included in Submission:
2
Image /page/2/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15. 2019
Surgical Instrument Service and Savings, Inc. Stephanie Mays Senior Regulatory Specialist, Quality Assurance and Regulatory Affairs (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K182828
Trade/Device Name: Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: March 19, 2019 Received: March 20, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
3
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and it is a blue square with a white star inside. The Renewal logo is on the right, and it is green and blue. Underneath the Renewal logo, it says "Full Circle Reprocessing".
K182828 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 | | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------|--------------------------|
| Contact/Prepared by | Stephanie Boyle Mays
Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • E: smays@medline.com | | | |
| Date Prepared | October 4, 2018 | | | |
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Carter-Thomason
Needle-Point Suture Passer Instrument Set | | |
| | Common or Usual Name | Suture Passer, Carter-Thomason CloseSure System | | |
| | Regulatory Name/Reference | Endoscope and accessories reprocessed, 21 CFR § 876.1500 | | |
| | Regulatory Class | Class II | | |
| | Product Code | NLM | Panel | Gastroenterology/Urology |
| | 510(k) Number | K980123 | | |
| Predicate Device | Proprietary or Trade Name | Carter-Thomason Needle-Point Suture Passer Instrument Set | | |
| | Common or Usual Name | Suture Passer, Carter-Thomason CloseSure System | | |
| | Regulatory Name/Reference | Endoscope and accessories, 21 CFR § 876.1500 | | |
| | Regulatory Class | Class II | | |
| | Product Code | GCJ | | |
| | Panel | Gastroenterology/Urology | | |
| | Manufacturer | Louisville Laboratories
2400 Crittenden Dr., Louisville, KY 40217-1865 | | |
| Device Description | The Medline ReNewal Reprocessed Carter-Thomason Suture Passer Set
(models CTI-512N, CTI-1015N, PG-15S, and PG-5/10) is a sterile, single-
case use, hand-held suture grasping device that is designed to pass suture
through soft tissue. | | | |
| Indications for use | The Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture
Passer is indicated to pass suture through soft tissues of the body during
endoscopic/laparoscopic surgery. | | | |
| 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 devices. K980123
Carter-Thomason Needle Point Suture Passer Instrument Set was used as
the primary predicate to support intended use, technological characteristics,
and functional performance specifications. | | | |
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Image /page/5/Picture/0 description: The image contains the Medline logo on the left, which is a blue square with a white cross and the word "MEDLINE" in white letters. To the right of the Medline logo is the text "ReNewal" in green, with the words "Full Circle Reprocessing" in smaller black letters below it. The letters "TM" are in the upper right corner of the word "ReNewal".
Traditional 510(k) Notification
Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer İnstrument Set
| Performance
Testing | The functional characteristics of the proposed devices have been evaluated
and found to be equivalent to the predicate devices based on the following
tests: |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • simulated use; |
| | • device integrity; |
| | • cleaning: |
| | ◦ protein, carbohydrates and hemoglobin; |
| | • biocompatibility: |
| | ◦ cytotoxicity, sensitization, irritation; pyrogenicity, and acute
systemic toxicity; |
| | • performance qualification; |
| | • sterilization validation; and |
- product stability.
Summary Table: Predicate and Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer Instrument Set device comparison chart.
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | Louisville Laboratories | ||
| Carter-Thomason Needle | |||
| Point Suture Passer | |||
| Instrument Set | Medline ReNewal | ||
| Reprocessed Carter- | |||
| Thomason Needle Point | |||
| Suture Passer Instrument | |||
| Set | As Stated | ||
| 510(k) | K980123 | K182828 | N/A |
| Model Numbers | CTI-512N | ||
| CTI-1015N | |||
| Carter-Thomason CloseSure | |||
| System XL | CTI-512N | ||
| CTI-1015N | |||
| PG - 15S | |||
| PG-5/10 | Same | ||
| Common Name | Endoscope and accessories | Endoscope and accessories | Same |
| Regulation No. | 21 CFR § 876.1500 | 21 CFR § 876.1500 | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | GCJ | NLM | As stated |
| Indications for | |||
| Use | The Needle-Point Suture | ||
| Passer is indicated to pass | |||
| suture through soft tissues of | |||
| the body during | |||
| endoscopic/laparoscopic | |||
| surgery. | The Medline ReNewal | ||
| Reprocessed Needle-Point | |||
| Suture Passer is indicated to | |||
| pass suture through soft | |||
| tissues of the body during | |||
| endoscopic/laparoscopic | |||
| surgery. | Same | ||
| Technological | |||
| Characteristics | The Carter-Thomason Suture | ||
| passer is a sterile, single-case | |||
| use, hand-held suture | |||
| grasping device that is | |||
| designed to pass suture | |||
| through soft tissue during | |||
| endoscopic/laparoscopic | |||
| surgeries. | The Carter-Thomason Suture | ||
| passer is a sterile, single-case | |||
| use, hand-held suture | |||
| grasping device that is | |||
| designed to pass suture | |||
| through soft tissue during | |||
| endoscopic/laparoscopic | |||
| surgeries. | Same |
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Image /page/6/Picture/0 description: The image contains two logos. The first logo is for Medline, and it features a blue square with a white cross inside. The word "MEDLINE" is written in white letters next to the cross. The second logo is for Renewal Full Circle Reprocessing. The word "Renewal" is written in green and blue letters, and the words "Full Circle Reprocessing" are written in black letters below the word "Renewal."
Traditional 510(k) Notification Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Ìnstrument Set