(33 days)
FOR USE IN INSTALLING SURGICAL DRAINS
The EuTrochar is a trocar used for the installation of surgical drains. The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement and to keep fingers away from the sharp point. Trocars have been used for more than a hundred years to create an incision in soft tissue for surgical drain tubing. Like other drain installation trocars, this instrument is a highly polished stainless steel rod of small diameter, normally 4 to 6mm in diameter and about 160mm long. One end of the rod is very sharply pointed and the other end has a hose barb for affixing tying. The rod is curved between the two ends so that it looks like a giant sailmaker's needle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EuTrochar device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety: No hazard to prospective patient | "No failures were experienced." "The conclusions of each tester were that there had been no failure and that the devices did not present a hazard to a prospective patient..." |
| Safety: No hazard to surgical personnel | "...nor to surgical personnel." |
| Functionality: Successful use by outside surgeons and support personnel | "Special Devices developed a Trials Protocol, which we consider a "bench trial." Employing plastic sheet as ersatz tissue, a series of EuTrochars and several Deployers were used in trials. No failures were experienced." |
| Functionality: Accurate drain placement | "The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement..." (Claim, not explicitly tested as a quantifiable criterion in the study description, but implied by the "no failures" outcome.) |
| Functionality: Keeping fingers away from sharp point | "The Deployer is different from the predicate drain installation trocars in that the protective cover "Sheath" is not removed by the surgeons' hand... With the Deployer opened, there is ample clearance tissue to fit between the sharp point of the EuTrochar and the Receiver target. Holding the Deployer by the handles, the surgeon and associates are clear of the sharp point..." |
| Functionality: Easy release from Receiver | "The EuTrochar, protected by the Sheath, is easily released from the Receiver." |
| Functionality: Cutting from tubing and discarding | "It is cut from the tubing and discarded into the hazardous waste depository." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: "Many drain installations were performed on dead animal tissue." and "Employing plastic sheet as ersatz tissue, a series of EuTrochars and several Deployers were used in trials."
- Sample Size:
- Animal Tissue: Not explicitly stated, but described as "Many." This indicates a qualitative assessment rather than a statistically robust sample size.
- Plastic Sheet ("Bench Trial"): Not explicitly stated how many "series of EuTrochars" or "several Deployers" were used, nor the number of trials total.
- Data Provenance:
- Country of Origin: United States (based on the company address and FDA submission).
- Retrospective or Prospective: The "bench trial" and tests on animal tissue were conducted prospectively by the device manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The text mentions "Technicians in Special Devices" and later "outside surgeons and support personnel" for the "bench trial." It's unclear how many individuals constituted "technicians" or "outside surgeons."
- Qualifications of Experts:
- Technicians: "Technicians in Special Devices performed exhaustive tests..." - No specific qualifications (e.g., years of experience, specific medical expertise) are provided beyond being "technicians."
- Outside Surgeons: "ascertain that the hardware could be used successfully by outside surgeons and support personnel..." - No specific qualifications are provided for the "outside surgeons."
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The phrase "The conclusions of each tester were that there had been no failure..." suggests individual assessments by "each tester" rather than a formal adjudication process (like 2+1 or 3+1 consensus). It appears to be based on direct observation and qualitative assessment by the individuals performing the tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The studies described are focused on the safety and basic functionality of the EuTrochar in a standalone context, not on its comparative effectiveness in improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was effectively done. The EuTrochar is a manual surgical instrument, not an algorithm. The "tests with prototype hardware using both plastic tissue and animal tissue" and the "bench trial" evaluate the device's standalone mechanical safety and functionality, without comparing its performance to human (surgeon) performance or evaluating human performance with and without the device. The device itself is the "standalone" element being tested.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Qualitative Observation/Expert Assessment: The "ground truth" for the tests appears to have been based on direct observation of the device's function, ease of use, and whether "failures were experienced" or if it "presented a hazard" by the "technicians" and "outside surgeons" involved in the trials.
- Functionality/Safety Outcomes: The primary outcomes were successful installation of drains, lack of failures, and absence of hazards.
8. The Sample Size for the Training Set
- Not applicable. The EuTrochar is a mechanical surgical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "prototype hardware" and "series of EuTrochars and several Deployers" used in testing would represent the specific instances of the device being evaluated, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML device, so there is no training set or associated ground truth establishment for a training set.
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MAY 18 2005
K050957
Page 183
510(k) Summary
Special Devices Incorporated 12493 Old Rough and Ready Hwy. Grass Valley, CA 95945 Telephone 530/273-6763 Fax 530/477-0583 Contact Name: Joseph J. Spranza III
March 26, 2905
Trade Name, EuTrochar
Common Name, trocar for installing surgical drains
Name of legally marketed devices.
The Davol Reliavac with PVC Drain, DVL3463 TLS Surgical Drainage System, 7 French Drain Kit trocar. Catalogue Number 6640.
Description. The EuTrochar is a trocar used for the installation of surgical drains. The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement and to keep fingers away from the sharp point. Trocars have been used for more than a hundred years to create an incision in soft tissue for surgical drain tubing. Like other drain installation trocars, this instrument is a highly polished stainless steel rod of small diameter, normally 4 to 6mm in diameter and about 160mm long. One end of the rod is very sharply pointed and the other end has a hose barb for affixing tying. The rod is curved between the two ends so that it looks like a giant sailmaker's needle.
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K050957 2 of 3
Intended Use. The EuTrochar is a trocar used for the installation of surgical drains.
Summary of technological characteristics of the device compared with the predicate devices. Like other drain installation trocars, this instrument is a highly polished stainless steel rod, curved in the middle of the length and having a sharp pointed end and a second end for tubing attachment. Beyond the similarities, there are several differences between the EuTrochar and predicate drain installation trocars. Predicate drain installation trocars have a soft plastic cover over the sharp pointed end. This cover must be removed before use. The surgeon or surgical assistant pulls this plastic cover off. Then, grasping the trocar in his hand or with pliers, the surgeon pushes the point into the area where he wants the drain tubing and forces the predicate trocar from within the surgical incision, through soft tissue to the outside. When the sharp pointed end emerges from the outside tissue, the surgeon typically grasps the emerging pointed end using pliers. He then pulls the trocar through the tissue flap and with it, on the trailing end of the trocar, comes the drain tubing. After cutting the trocan from the drain tubing, the surgeon or assistant must replace the protective cover onto the sharp point.
The EuTrochar is different from the predicate drain installation trocars in that the protective cover "Sheath" is not removed by the surgeons' hand. The protected EuTrochar, (Sheath covering the sharp point) is inserted into a handle, ("Deployer") into which it is automatically securely fastened. Grasping the Deployer by the handles, the surgeon opens it, releasing the EuTrochar from the protective Sheath remains in the head (Receiver) of the Deployer and acts as a target for the sharp point when later the Deployer is closed, returning the sharp point on the EuTrochar into the Sheath. With the Deployer opened, there is ample clearance tissue to fit between the sharp point of the EuTrochar and the Receiver target. Holding the Deployer by the handles, the surgeon and associates are clear of the sharp point as it is placed at the desired spot for the drain inside the soft tissue flap. The Deployer is positioned such that the target is placed at the desired exit position of the drain tubing. Squeezing the handles closes the Deployer and therefore advances the EuTrochar through the soft tissue and back into the Sheath. Since the target supports the tissue, the EuTrochar is advanced through the soft tissue, without fingers or hands near the
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sharp point. And, the drain tube will be in the exact position desired by the surgeon. The Sharp point of automatically locked into the Sheath when the Deployer is closed. The tubing Eurrochar is and drain tubing through the soft tissue. No fingers come close to the point, as it is enclosed with the Sheath. When the tubing has been pulled far enough, the EuTrochar, protected by the are work.
Sheath, is easily released from the Receiver. It is cut from the tubing and discarded into the hazardous waste depository.
Thus, the differences between predicate drain installation trocars and the EuTrochar are in the protective cover over the sharp point and in the handle (Deployer) which replaces the need for pliers and keeps fingers clear of the sharp point.
This product has no Performance Standards. Technicians in Special Devices performed exhaustive tests with prototype hardware using both plastic tissue and animal tissue. Many drain installations were performed on dead animal tissue. Additionally, as an aid to writing the Technique Manual and to ascertain that the hardware could be used successfully by outside surgeons and support personnel, Special Devices developed a Trials Protocol, which we consider a "bench trial." Employing plastic sheet as ersatz tissue, a series of EuTrochars and several Deployers were used in trials. No failures were experienced.
The conclusions of each tester were that there had been no failure and that the devices did not present a hazard to a prospective patient nor to surgical personnel.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
MAY 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph John Spranza, III President Special Devices Incorporated 12493 Old Rough and Ready Highway Grass Valley, California 95945
Re: K050957
Trade/Device Name: EuTrochar Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: MDM Dated: March 21, 2005 Received: April 15, 2005
Dear Mr. Spranza:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to Milly 20, 1978, is accordance with the provisions of the Federal Food, Drug, de rices mat have been require approval of a premarket approval application (PMA). and Costine (110. (110.) that the device, subject to the general controls provisions of the Act. The r ou may, mereloro, maries 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 (Special Controls) or class III (PMA), it your device to such additional controls. Existing major regulations affecting your device it may of sucjoct to Edan of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can or tound in the overouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase be act nove a determination that your device complies with other requirements of the Act than + Drederal 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); good manufacturing practice requirements as set OFF in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Joseph John Spranza, III
This letter will allow you to begin marketing your device as described in your Section 510(k) rran roket notification. The FDA finding of substantial equivalence of your device to a legally promation in the 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), please If you the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Ru Ohi
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(K) Number (if known): K050957
Device Name: EuTrochar
Indications For Use: FOR USE IN INSTALLING SURGICAL DRAINS
Prescription Use: By Surgeon (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
BELOW THIS LINE-CONTINUE ON (PLEASE DO NOT WRITE ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devices Evaluation (ODE)
. I, studitive
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Judith Areen
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§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 the limitations in § 878.9.