(86 days)
The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
This document describes the premarket notification for a Reprocessed Covidien Trocar (K172093). The study contained within this document evaluates the performance of the reprocessed device compared to the original equipment manufacturer (OEM) device.
Here's an analysis of the provided information according to your criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, the performance testing aims to demonstrate equivalence to the new OEM device. Therefore, the "acceptance criteria" here implicitly means "performance equivalent to the new OEM device."
| Performance Test Category | Specific Test | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|---|
| Functional Testing | Seal Drag | Equivalent to new OEM device | Side-by-side testing of reprocessed devices to an identical new OEM device was performed, indicating satisfactory functional performance. (Specific numerical results not provided) |
| Seal Leakage | Equivalent to new OEM device | Side-by-side testing of reprocessed devices to an identical new OEM device was performed, indicating satisfactory functional performance. (Specific numerical results not provided) | |
| Insertion, Fixation, & Removal Force | Equivalent to new OEM device | Side-by-side testing of reprocessed devices to an identical new OEM device was performed, indicating satisfactory functional performance. (Specific numerical results not provided) | |
| Cleaning Validation | Residual Protein and Hemoglobin | As clean as a new OEM device | Cleaning validation performed to ensure reprocessing steps thoroughly cleaned and sanitized devices to be as clean as a new OEM device. (Specific numerical thresholds or results not provided) |
| Visual Inspection | As clean as a new OEM device | Cleaning validation performed to ensure reprocessing steps thoroughly cleaned and sanitized devices to be as clean as a new OEM device. (Specific observational results not provided) | |
| Cleaning Performance Qualification | As clean as a new OEM device | Cleaning validation performed to ensure reprocessing steps thoroughly cleaned and sanitized devices to be as clean as a new OEM device. (Specific results not provided) | |
| Product Stability | Shelf Life Testing (1-year Accelerated Aging) | Maintained performance after aging | 1-year Accelerated Aging was performed. (Specific stability results not provided) |
| Sterilization & Packaging | EtO Sterilization Testing | Sterilized effectively | EtO Sterilization Testing was performed. (Specific results not provided) |
| Simulated Shipment Testing | Maintained integrity after shipment | Simulated Shipment Testing was performed. (Specific results not provided) | |
| Biocompatibility Testing | Cytotoxicity | Biocompatible | Testing was performed. (Specific results not provided) |
| Irritation and Sensitization | Biocompatible | Testing was performed. (Specific results not provided) | |
| Acute Systemic | Biocompatible | Testing was performed. (Specific results not provided) | |
| EtO Residuals Testing | Below acceptable limits | Testing was performed. (Specific results not provided) | |
| Material Mediated Pyrogenicity | Non-pyrogenic | Testing was performed. (Specific results not provided) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact sample size for the "test set" (i.e., how many reprocessed trocars were tested against how many new OEM trocars for each performance test). It only states that "side-by-side testing of the reprocessed devices to an identical new OEM device" was performed.
- Data Provenance: The data is based on benchtop performance testing conducted by ReNovo, Inc. It is prospective testing designed to demonstrate the performance of their reprocessed devices. The country of origin of the data is not explicitly stated but is implied to be where ReNovo, Inc. conducted its testing (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This study does not involve human readers or interpretation of medical images/data where expert ground truth establishment would be required. The evaluation is based on objective physical and chemical testing.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation or consensus. The performance tests are objective laboratory measurements.
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. This is a study on the reprocessing of a physical medical device (trocar), not an AI imaging or diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the reprocessed device itself, which was evaluated through benchtop testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is essentially the performance and characteristics of a new, legally marketed OEM Covidien Trocar. The reprocessed device's performance is compared against this established benchmark.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set" in this context. The study focuses on evaluating the reprocessing process and the final reprocessed product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device evaluation.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 5, 2017 Renovo, Inc. % Mr. Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K172093
Trade/Device Name: Reprocessed Covidien Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: October 3, 2017 Received: October 3, 2017
Dear Mr. Packard:
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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
{1}------------------------------------------------
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 (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 (DICE) 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, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Center for Devices and Radiological Health
Office of Device Evaluation
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K172093
Device Name Reprocessed Covidien Trocars
Indications for Use (Describe)
The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K172093
Page 1 of 3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- SUBMITTER 1. ReNovo, Inc. Mark K. Wells 340 SW Columbia St. Bend OR, 97702 USA Tel: +1.541.422.8880 Fax: +1.541.422.8881
CONTACT PERSON II.
Robert Packard, President of Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 USA Tel: +1.802.281.4318 Email: rob@13485cert.com
Date Prepared: October 2, 2017
III. DEVICE
| Name of Device: | Reprocessed Covidien Trocar |
|---|---|
| Classification Name: | Laparoscope, General & Plastic Surgery, Reprocessed |
| Regulation: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product Classification Code: | NLM |
IV. PREDICATE (OEM) DEVICE
| Predicate Manufacturer: | Covidien (Original 510(k) was issued to United States Surgical, a division of Tyco Healthcare Group LP |
|---|---|
| Predicate Trade Name: | autosuture™ Modified VERSAPORT™ Trocar with Fixation Sleeve |
| Predicate 510(k): | K062326 |
No reference devices were used in this submission.
V. DEVICE DESCRIPTION
A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
INDICATIONS FOR USE VI.
Reprocessed Covidien Trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
{4}------------------------------------------------
K172093
Page 2 of 3
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE OEM VII. PREDICATE DEVCE
The fundamental technological characteristics of the subject device are identical to the predicate (OEM).
The following characteristics were compared between the subject device and the OEM device in order to demonstrate substantial equivalence:
- · Indications for Use The predicate and subject device have the same indications for use, both are indicated for "use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry."
- · Materials The materials in the subject device are identical to the predicate with exception to the lubricant. The lubricants are not identical, but are equivalent in functional and biocompatible performance. .
- · Design The predicate and subject devices have identical designs.
- · Energy Source Neither the predicate nor the subject device require power or an energy source.
- · Performance Testing The subject devices are reprocessed versions of the predicate (OEM) devices. The OEM devices are performance-tested cleared medical devices; therefore the performance testing consisted of side-by-side testing of the reprocessed devices to an identical new OEM device. This testing included seal drag, seal leakage, insertion, fixation, and removal testing.
- Cleaning Validation - While it is very important to test the performance of the reprocessed device to ensure it performs as new; an important part of the risk management of a reprocessed device is the need to ensure cleanliness. A cleaning validation was performed to ensure that the reprocessing steps thoroughly cleaned and sanitized the devices so that they were as clean as a new OEM device.
PERFORMANCE DATA VIII.
The following performance data was provided in support of the substantial equivalence determination.
Performance Testing
- · Functional
- Seal Drag o
- Seal Leakage O
- Insertion, Fixation, and Removal Force Test O
- Product Stability
- Shelf Life Testing 1-year Accelerated Aging O
- Cleaning Validation
- Residual Protein and Hemoglobin ●
- Visual Inspection ●
- Cleaning Performance Qualification ●
- Sterilization and Packaging
- EtO Sterilization Testing ●
- Simulated Shipment Testing ●
{5}------------------------------------------------
Page 3 of 3
Biocompatibility Testing
- · Cytotoxicity
- · Irritation and Sensitization
- · Acute Systemic
- · EtO Residuals Testing
- · Material Mediated Pyrogenicity
Electrical Safety and EMC Testing
Electrical safety and EMC testing were not applicable.
Animal Testing
Animal performance testing was not required to demonstrate safety and effectiveness.
Clinical Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed Covidien Trocar. Substantial equivalence is based upon benchtop performance testing.
IX. CONCLUSIONS
Side by side testing ensured that the reprocessed trocars performed equivalently to the same device new from the OEM. Cleaning validations ensured that the devices are reprocessed and cleaned to the condition of a new OEM device. Therefore, based on a comparison of technological characteristics, indications for use, and performance comparison data, it can be concluded that the proposed Reprocessed Covidien Trocars are substantially equivalent to the OEM predicate device.
§ 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.