(87 days)
Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures. Trocars are single patient used devices.
AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times. Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused. Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing.
The provided text describes a 510(k) submission for reprocessed disposable trocars by Adven Medical, Inc. (AMI). It focuses on establishing substantial equivalence to new disposable trocars and the reprocessing protocol. However, the document does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the specifics of a study proving device performance against those criteria.
Specifically, the document states: "AMI has performed numerous tests to validate its reprocessing protocol." but does not elaborate on:
- The specific acceptance criteria used for these tests.
- The reported performance statistics from these tests.
- The sample size, data provenance, number of experts, adjudication methods, or ground truth details for these tests.
- Any information regarding MRMC studies or standalone algorithm performance.
Therefore, many sections of your request cannot be fulfilled with the provided text. I will provide the information that is available.
Acceptance Criteria and Study for Reprocessed Disposable Trocars
Based on the provided text, the primary "acceptance criteria" for the reprocessed trocars hinge on demonstrating that they remain "safe and effective for its intended use" after reprocessing, are "able to withstand the necessary cleaning and sterilization process," and that "the physical characteristics or quality of the device will not be adversely effected." The foundational study mentioned is the validation of AMI's reprocessing protocol.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Implied from 510(k) Clearance) |
|---|---|---|
| Safety and Effectiveness | Device remains "safe and effective for its intended use" after reprocessing. | The FDA's 510(k) clearance (K013987) indicates that the "device is substantially equivalent" to legally marketed predicate devices, implying that AMI successfully demonstrated the reprocessed trocars meet the same safety and effectiveness standards as new, single-use trocars. |
| Physical Characteristics/Quality | "The physical characteristics or quality of the device will not be adversely affected" by reprocessing. | FDA clearance for marketing suggests that physical characteristics and quality were maintained to a degree comparable to the original, new device, supporting the "substantially equivalent" determination. |
| Reprocessing Durability | Device is "able to withstand the necessary cleaning and sterilization process." Each trocar can be reprocessed "up to two times." | The approval of the reprocessing protocol (Control Document Number 40005) and the statement that AMI "will reprocess each disposable trocar up to two times" indicates that testing confirmed the device's ability to endure the specified reprocessing steps while maintaining functionality and integrity for the stated number of cycles. Trocars not meeting the protocol are "rejected." |
| Substantial Equivalence to Predicate Device | The reprocessed device is "substantially equivalent" to predicate devices currently on the market for single use, in terms of indications for use and technological characteristics. Reprocessed trocars provide "a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures." | The FDA's 510(k) clearance explicitly states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the core finding of the FDA. The predicate devices are identified as trocars sold by original manufacturers and cleared for single use (KAB, KBG, KCI, FBQ, FBM, GCJ, DRC). This equivalence extends to the stated "Indications For Use." |
2. Sample size used for the test set and the data provenance:
- The document states: "AMI has performed numerous tests to validate its reprocessing protocol." However, it does not specify the sample size for these tests.
- Data Provenance: The origin of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided text. It can be inferred that the testing would have been conducted primarily in the USA, as AMI is a US-based company submitting to the US FDA. The nature (retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The validation tests mentioned likely refer to engineering and biocompatibility testing rather than expert-based clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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:
- No MRMC study information is provided. This type of study is not relevant to the validation of a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a reprocessed surgical instrument, the "ground truth" for the validation tests would likely involve a combination of:
- Functional Testing: Demonstrating the device continues to perform its intended mechanical function (e.g., proper insertion, seal integrity, port function) after reprocessing.
- Material Integrity Testing: Ensuring no degradation of materials, corrosion, or structural compromise.
- Cleaning Efficacy/Sterilization Validation: Demonstrating successful removal of bioburden and successful sterilization, typically through laboratory methods (e.g., protein residue tests, sterility tests).
- Biocompatibility Testing: Ensuring reprocessed devices remain biocompatible.
- Specific details on how these were established are not provided, beyond the general statement of "numerous tests".
8. The sample size for the training set:
- This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.
9. How the ground truth for the training set was established:
- This concept is not applicable as the device is a physical surgical instrument, not an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the text "Adven Medical, Inc." in a bold, italicized font. The text is underlined with a thick black line. The words are arranged horizontally, with "Adven" on the left, "Medical" in the center, and "Inc." on the right. The text appears to be a logo or heading.
MAR 1 2002
KO13987
510(k) SUMMARY
Classification Name:
1001 Slaton Hwv. Lubbock, Texas 79404
Common/Usual Name: Trade/Proprietary:
Trocar - KAB, KBG, KCI, FBQ, FBM, GCJ, DRC Trocar Reprocessed Disposable Trocars
Mark W. Aldana
Contact:
Summary:
AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times.
Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused.
Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing.
AMI believes that reprocessed trocars can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
AMI reprocesses only trocars that are currently sold on the market and which have met premarket requirements by the original manufacturer for single use.
AMI Reprocessed Trocars addressed in this submission are the same devices that are currently sold on the market as "disposable" by the original manufacturer. The devices identified in this premarket notification are the predicate devices and therefore substantially equivalent to trocars currently on the market.
The concept of marketing reprocessed trocars is similar to the concept of marketing resharpenable surgical saw blades which was found substantially equivalent by FDA in 510(K) 940501 (submitted by Adven Medical, Inc. and cleared on June 28, 1994).
AMI has performed numerous tests to validate its reprocessing protocol.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2002
Mr. Mark W. Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404
Re: K013987
Trade/Device Name: Reprocessed Disposable Trocars Regulation Number: 870.1390 Regulation Name: Trocar Regulatory Class: II Rogalatory - KBG, KCI, FBQ, FBM, GCJ, DCR Dated: December 3, 2001 Received: December 4, 2001
Dear Mr. Aldana:
We have reviewed your Section 510(k) premarket notification of intent to market the device in diedic We have reviewed your Section 3 ro(x) premained is substantially equivalent (for the indications
referenced above and have determined the device is substantially interests on felerenced above and nave acterimined by marketed predicate devices marketed in interscate for use stated in the encrosure) to regard) the enactment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the exactions of the Federal Food. Drug. devices that have been recalise in acceracited in assessor will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The Tou may, uncrerore, mance are act include requirements for annual registration. listing of general controls provisions of the riot labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to such additions, 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 I loase be advised that I Dr brisean that your device complies with other requirements of the Act that I DA has made a determinalations administered by other Federal agencies. You must or any I edelul statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the Fet 8 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607); adoming (Dr CFR Part 820); and if applicable, the electronic forth in the quality of over of sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Mark W. Aldana
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510)k) Number: K013987
Reprocessed Disposable Trocars Device Name:
Indications For Use:
Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.
Trocars are single patient used devices.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for Mark N Milunson | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K013987 |
ﻪ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.