(192 days)
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.
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.
The provided text describes a 510(k) submission for a reprocessed medical device, the "Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set." This submission aims to prove substantial equivalence to an existing predicate device, not necessarily to meet specific performance criteria as one might find for novel AI/software as a medical device (SaMD) products.
Therefore, the structure of the acceptance criteria and the study that proves the device meets them will differ significantly from what would be expected for an AI-based diagnostic tool. The "acceptance criteria" here are based on demonstrating that the reprocessed device performs functionally identically and safely to the original, legally marketed device.
Here's an analysis based on the provided text, using the requested categories where applicable:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a quantitative table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it describes a series of tests conducted to demonstrate equivalence. The "acceptance criteria" are implicitly that the reprocessed device performs equivalently to the original device in key functional and safety attributes.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Functional Equivalence | Demonstrated through "simulated use" and "device integrity" testing. The reprocessed device is stated to have "identical" technological characteristics and "functional performance specifications" to the predicate device. |
| Cleaning Effectiveness | Demonstrated by testing for residues: protein, carbohydrates, and hemoglobin. No specific numerical thresholds or residual levels are provided, but the successful completion of these tests indicates the device meets the reprocessor's cleaning standards. |
| Biocompatibility | Demonstrated by testing for: cytotoxicity, sensitization, irritation, pyrogenicity, and acute systemic toxicity. The implication is that the reprocessed device is as biocompatible as the original. |
| Performance Qualification | Not explicitly detailed, but stated as a conducted test, implying the device performs as expected under defined conditions. |
| Sterilization Validation | Stated as a conducted test, implying the device can be consistently sterilized to appropriate levels for single-use, sterile devices. |
| Product Stability | Stated as a conducted test, implying the device maintains its characteristics over its defined shelf-life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the number of individual reprocessed devices tested for each category (e.g., how many devices were subjected to simulated use, or cleaning tests). It simply lists the types of tests performed.
- Data Provenance: Not explicitly stated regarding the origin of the reprocessed devices used for testing (e.g., country of origin of the used devices before reprocessing). The tests are described as being performed by the reprocessor, Medline ReNewal. The nature of the study is retrospective in the sense that existing used devices are collected for reprocessing and subsequent testing, although the testing itself is prospective on those reprocessed units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this device type and submission. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is primarily relevant for diagnostic devices (especially AI/SaMD). For a reprocessed surgical instrument, the "ground truth" is its functional performance and safety profile, which is established through objective, standardized engineering and biological testing, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers or algorithms interpret data and discrepancies need to be resolved. For evaluating the physical and biological properties of a reprocessed surgical instrument, such methods are irrelevant. Test results are based on objective measurements against predefined specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading X-rays). This device is a surgical instrument used to pass suture, not a diagnostic tool, and involves no "human readers" in the context of interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this reprocessed device is established through:
- Engineering Performance Specifications: The device must meet the original manufacturer's specifications for mechanical function, integrity, and dimensions.
- Cleaning Efficacy Standards: Demonstrated by the absence of significant biological residues.
- Sterility Assurance Levels: Proven through sterilization validation.
- Biocompatibility Standards: Proven through direct testing on the reprocessed materials.
These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology, nor are they based on patient outcomes data for the pre-market submission (though post-market surveillance would track adverse events).
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI model, this question is irrelevant to the reprocessing of a surgical instrument.
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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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| OEM DeviceModela | Device Name | OEM |
|---|---|---|
| CTI-512N | Carter Thomason CloseSure System(Carter Thomason Suture Passer, 5-mmPilot Guide, 10/12-mm Pilot Guide) | LouisvilleLaboratories, Inc. |
| CTI-1015N | Carter Thomason CloseSure System(Carter Thomason Suture Passer,10/12-mm Pilot Guide, 115-mm PilotGuide) | LouisvilleLaboratories, Inc. |
| PG-15S | 15-mm Pilot Guide | LouisvilleLaboratories, Inc. |
| PG-5/10 | 5-mm Pilot Guide, 10/12 mm Pilot Guide | LouisvilleLaboratories, Inc. |
| a OEM = original equipment manufacturer. |
K182588 Reprocessed Carter-Thomason CloseSure Devices included in Submission:
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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
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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 MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 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-ThomasonNeedle-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 Laboratories2400 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 suturethrough soft tissue. | |||
| Indications for use | The Medline ReNewal Reprocessed Carter-Thomason Needle-Point SuturePasser is indicated to pass suture through soft tissues of the body duringendoscopic/laparoscopic surgery. | |||
| Technological Characteristics | The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate device. The proposeddevices are a reprocessed version of the predicate devices. K980123Carter-Thomason Needle Point Suture Passer Instrument Set was used asthe 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
| PerformanceTesting | The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices based on the followingtests: |
|---|---|
| • simulated use; | |
| • device integrity; | |
| • cleaning: | |
| ◦ protein, carbohydrates and hemoglobin; | |
| • biocompatibility: | |
| ◦ cytotoxicity, sensitization, irritation; pyrogenicity, and acutesystemic 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 | |
|---|---|---|---|
| DeviceCharacteristics | Louisville LaboratoriesCarter-Thomason NeedlePoint Suture PasserInstrument Set | Medline ReNewalReprocessed Carter-Thomason Needle PointSuture Passer InstrumentSet | As Stated |
| 510(k) | K980123 | K182828 | N/A |
| Model Numbers | CTI-512NCTI-1015NCarter-Thomason CloseSureSystem XL | CTI-512NCTI-1015NPG - 15SPG-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 forUse | The Needle-Point SuturePasser is indicated to passsuture through soft tissues ofthe body duringendoscopic/laparoscopicsurgery. | The Medline ReNewalReprocessed Needle-PointSuture Passer is indicated topass suture through softtissues of the body duringendoscopic/laparoscopicsurgery. | Same |
| TechnologicalCharacteristics | The Carter-Thomason Suturepasser is a sterile, single-caseuse, hand-held suturegrasping device that isdesigned to pass suturethrough soft tissue duringendoscopic/laparoscopicsurgeries. | The Carter-Thomason Suturepasser is a sterile, single-caseuse, hand-held suturegrasping device that isdesigned to pass suturethrough soft tissue duringendoscopic/laparoscopicsurgeries. | 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
§ 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.