(203 days)
The DeRoyal Industries Disposable Surgical Trocar/Cannula is a single patient use disposable device intended for use during operative and/or diagnostic surgery to puncture/penetrate the abdominal wall and to serve as a port of entry for laparoscopic instruments (i.e. laparoscope, forceps, scissors, aspiration/irrigation cannula, etc.).
The DeRoyal Disposable Surgical Trocar/Cannula is a disposable single patient use device fabricated from surgical grade stainless steels, surgical grade aluminum, and biocompatible medical grade polymers. The device comes in 5, 8, 10/11, and 12 mm diameter cannulas. Cannula length ranges from 75 mm - 100 mm. The cannula diameter can be used with equivalent diameter instruments or scopes, but is also equipped with a detachable integrated reducer diaphragm on all large sizes to bring the compatible diameter down to 5 mm. The trocar/cannula is supplied with either a pyramidal tip cutting trocar with safety shield or with a blunt tip trocar/cannula without safety shield for use with open laparoscopic procedures. The cutting trocar/cannula has a tri-segmented safety shield which is comprised of three shield segments that retract and advance independently. The cannula body has a luer fitting to accommodate insufflation apparatus and an external lever for manual opening of the internal flapper valve for rapid desufflation. The cannula shaft is radiotranslucent.
The acceptance criteria and the study proving the device meets them are not explicitly detailed in the provided text in the way one would typically find for performance metrics of a diagnostic or treatment device. This submission is for a medical device (Disposable Surgical Trocar/Cannula) under a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the context of AI/software.
The provided information emphasizes technological characteristics and intended use for comparison. The core of the submission is to show that the new device is as safe and effective as existing legally marketed predicate devices.
However, based on the provided text, here's an attempt to extract relevant information and highlight what is missing given the structure of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic/Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (DeRoyal Industries) |
|---|---|
| Intended Use: Application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. | Same |
| Pyramidal Tip Present | Yes (Same) |
| Safety Shield Present | Yes (Same) |
| Reducer to Accommodate Smaller Instruments Present | Yes (Same) |
| Sterility | Sterile (Same) |
| Materials: Polymers, silicone rubber, stainless steel, and aluminum. | Polymers, silicone rubber, fiberglass, stainless steel, and aluminum. |
| Design: Similar/same to predicate devices. | Similar/same to predicate devices. |
Note: "Acceptance Criteria" here are inferred from the shared characteristics with predicate devices that formed the basis of the substantial equivalence determination. There are no specific quantitative performance metrics (e.g., success rates, complication rates, force required for penetration) provided in this summary that would typically be associated with explicit acceptance criteria for a clinical study. The "reported device performance" is essentially that it matches the predicate device in key design and material characteristics.
Missing Information (Not provided in the text; these questions are more applicable to software/AI devices or clinical trials for novel devices):
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. This is a physical medical device, and the submission focuses on design and material equivalence, not clinical study data, in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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 not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for this device's substantial equivalence is its comparability to existing devices in terms of design, materials, and intended use as assessed by the FDA.
- The sample size for the training set: Not applicable. This is not an AI/software device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/software device.
Summary of the "Study" and How it Meets Criteria:
The "study" in this context is not a traditional clinical trial or performance study with quantified metrics as you might expect for an AI algorithm or a novel therapeutic. Instead, it is a substantial equivalence comparison to legally marketed predicate devices.
The text states:
- "The DeRoyal Disposable Surgical Trocar/Cannula has similar/same technological characteristics as the predicate devices in that they are comprised of similar design, materials, and are intended to be used as a port of entry for laparoscopic instruments."
- "The proposed device has the same intended use and the same basic technology as the legally marketed predicate devices identified in the premarket notification submission."
- "The proposed device contains, in some combination, similar/same features, materials, and design as the predicate devices and does not pose any new questions concerning safety and effectiveness."
Conclusion: The device meets the implied "acceptance criteria" by demonstrating that its technological characteristics, intended use, materials, and design are substantially equivalent to those of existing, legally marketed predicate devices (Auto Suture® Surgiport® Disposable Trocar & Sleeve and Ethicon Endopath Disposable Surgical Trocar and Sleeve). This process, sanctioned by the FDA's 510(k) pathway, indicates that the device is considered as safe and effective as its predicates without requiring new clinical performance data to directly prove its efficacy or safety.
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510(k) SUMMARY: DEROYAL INDUSTRIES, INC. DISPOSABLE SURGICAL TROCAR/CANNULA
-
(1) DeRoval Industries 200 DeBusk Lane Powell. TN 37849
Camille Matlock Contact Person: (423) 938-7828 Telephone: Date Summary Prepared: December 18, 1997 -
Trade or Proprietary Name: none established (2)
Common Name (s):
Disposable Surgical Trocar/Cannula
Disposable Surgical Blunt tip Trocar/Cannula
Classified Name:
Endoscope and accessories, & 876.1500, Class II
-
Auto Suture® Surgiport® Disposable Trocar (3) Predicates: & Sleeve (510(k) nos. K862611. K874879, K900487, K903419)
Ethicon Endopath Disposable Surqical Trocar and Sleeve (510(k) nos. K912398, K924035, K932282) -
(4) Description of Device:
The DeRoyal Disposable Surgical Trocar/Cannula is a disposable single patient use device fabricated from surgical grade stainless steels, surgical grade aluminum, and biocompatible medical grade polymers.
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The device comes in 5, 8, 10/11, and 12 mm diameter cannulas. Cannula length ranges from 75 mm - 100 mm. The cannula diameter can be used with equivalent diameter instruments or scopes, but is also equipped with a detachable integrated reducer diaphragm on all large sizes to bring the compatible diameter down to 5 mm. The trocar/cannula is supplied with either a pyramidal tip cutting trocar with safety shield or with a blunt tip trocar/cannula without safety shield for use with open laparoscopic procedures. The cutting trocar/cannula has a tri-segmented safety shield which is comprised of three shield segments that retract and advance independently.
The cannula body has a luer fitting to accommodate insufflation apparatus and an external lever for manual opening of the internal flapper valve for rapid desufflation. The cannula shaft is radiotranslucent.
- (5) Intended Use:
The DeRoval Disposable Surgical Trocar/Cannula is a single patient use disposable device intended for use during operative and/or diagnostic surgery to puncture/penetrate the abdominal wall and to serve as a port of entry for laparoscopic instruments (i.e., laparoscope, forceps, scissors, aspiration/irrigation cannula, etc.).
| Characteristics | Predicate Devices | DeRoyal Industries |
|---|---|---|
| Intended Use | Application in thoracic, gynecologiclaparoscopy, and other abdominalprocedures to establish a path of entryfor endoscopic instruments. | Same |
| Pyramidal Tip | Yes | Same |
| Safety Shield | Yes | Same |
| Reducer to AccommodateSmaller Instruments | Yes | Same |
| Sterility | Sterile | Same |
| Materials | Polymers, silicone rubber, stainless steel,and aluminum. | Polymers, silicone rubber, fiberglass,stainless steel, and aluminum. |
- (6) Technological Characteristics:
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The DeRoyal Disposable Surgical Trocar/Cannula has similar/same technological characteristics as the predicate devices in that they are comprised of similar design, materials, and are intended to be used as a port of entry for laparoscopic instruments.
Conclusion: (7)
The proposed device has the same intended use and the same basic technology as the legally marketed predicate devices identified in the premarket notification submission. The proposed device contains, in some combination, similar/same features, materials, and design as the predicate devices and does not pose any new questions concerning safety and effectiveness.
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Image /page/3/Picture/0 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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 1998
Ms. Camille Matlock Regulatory Affairs DEROYAL Industries, Inc. 200 DeBusk Lane Powell. TN 37849
Re: K974763
Disposable Surgical Trocar/Cannula Dated: April 16, 1998 Received: April 17, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
Dear Ms. Matlock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K974763 510(k) Number (if known): Disposable Surgical Trocar/Cannula Device Name:
Indications for Use:
The DeRoyal Industries Disposable Surgical Trocar/Cannula is a single patient use disposable device intended for use during operative and/or diagnostic surgery to puncture/penetrate the abdominal wall and to serve as a port of entry for laparoscopic instruments (i.e. laparoscope, forceps, scissors, aspiration/irrigation cannula, etc.).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974763
Prescription Use (Per 21 CFR § 801.109)
OR
Over-The-Counter Use
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.