(86 days)
The Andrews Introducer™ is specifically designed for the insertion of intercostal chest tubes.
The Andrews Introducer™ is a reusable surgical forceps made of surgical steel that is specifically designed for the insertion of chest tubes. The Andrews Introducer™ is a three-limbed forceps and has three major features:
- A pivot joint at the fulcrum that opens the tips when the handles are closed using the stronger gripping force of the hand. The extent to which the tips open has been limited so as to reduce the trauma to the intercostal muscle.
- A vertical extension on each blade that creates a circular channel which is more accurately and appropriately shaped to allow easy passage of the chest tube. The distance between the vertical blades at the fulcrum is 10.7 millimetres, sufficient-to accommodate the diameter of a 32 gauge chest tube, expanding to 22mm at the.
- A third limb that is attached to the two main limbs through the pivot joint. It is held equidistant from the two main limbs by two leaf springs, which also close the tips when force is relieved from the handles. There is also a grip on the distal end of the third limb to hold the chest tube in position on the instrument for more rapid insertion once the channel has been created.
Here's a breakdown of the acceptance criteria and the study details for the Andrews Introducer™, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary End-point: Successful and accurate placement of the chest tube. | Chest tube inserted successfully without the trocar in all 30 cases. No complications occurred. |
| Secondary Criteria: Ease of use relative to existing methods. | Rated as "significantly easier relative to experience of use of the Roberts forceps in all specified aspects." |
| Safe use during insertion. | "Can be used to insert intercostal chest drain safely" |
| Efficient use during insertion. | "Can be used to insert intercostal chest drain... efficiently" |
| Ability to insert without a trocar or other instrument. | "Can be used to insert intercostal chest drain safely and efficiently without using the trocar or any other instrument." |
Important Note: The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "95% successful placement rate"). Instead, it presents the results of the feasibility study as evidence that the device meets the intended use and offers improvements over predicate devices. The "acceptance criteria" here are inferred from the study's endpoints and reported outcomes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 30 patients
- Data Provenance:
- Country of Origin: Not explicitly stated, but the applicant's address is in Dublin, Ireland, which suggests the study may have been conducted there.
- Retrospective or Prospective: Prospective. The study was a "clinical feasibility study of the use of the Andrews Introducer™ in an elective surgical setting" where tubes "were instead inserted using the Andrews Introducer™." This indicates a planned intervention for data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not explicitly state the "number of experts" or their "qualifications" involved in establishing ground truth for the test set.
- Instead, the assessment of "successful and accurate placement" and the questionnaire ratings were completed by the "operators" who inserted the chest tubes. These operators would be medical professionals (likely surgeons or cardiothoracic surgeons) trained in chest tube insertion.
- The document doesn't specify any independent review or external expert consensus on the "ground truth" of successful placement; it implicitly relies on the operator's assessment during the procedure.
4. Adjudication Method for the Test Set
- An explicit adjudication method (e.g., 2+1, 3+1) is not described in the provided text.
- The determination of "successful and accurate placement" appears to have been made by the operating physician(s) at the time of the procedure without a described independent adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense involving multiple human readers assessing cases with and without AI assistance.
- The study was a clinical feasibility study comparing the device (Andrews Introducer™) to previous experience with a different device (Roberts forceps), not an AI algorithm assisting human readers.
- The comparison was qualitative based on operator experience ("rated as significantly easier relative to experience of use of the Roberts forceps").
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, in a manner of speaking, the study was a "standalone" performance study for the device itself.
- The Andrews Introducer™ is a surgical tool, not an AI algorithm. Therefore, the "standalone" performance here refers to its direct application in surgery by a human operator, without any AI component or "human-in-the-loop" interaction in the context of an AI algorithm. The device's performance was evaluated based on its use by the operators.
7. Type of Ground Truth Used
- The ground truth for the test set was primarily based on clinical outcome and operator assessment:
- "Successful and accurate placement of the chest tube" as assessed by the operating physician/team.
- Absence of complications.
- Subjective ratings of ease of use by the operators.
8. Sample Size for the Training Set
- Not applicable / Not explicitly stated. This device is a manual surgical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and refinement would have involved engineering principles and potentially pre-clinical testing, but not a data-driven "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a manual surgical instrument, there is no "training set" for which ground truth would be established in the context of AI. The design and manufacturing would adhere to established surgical instrument standards and engineering specifications.
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KC23173
SECTION 10 -------------------------------------------------------------------------------------------------------------------------------------------------------------------
DEC 1 8 2002
SUBMITTER DETAILS
APPLICANTS NAME:
ADDRESS:
16 GROVE LAWN, MALAHIDE, Co. DUBLIN, IRELAND.
TELEPHONE NUMBER: -353-87-239 2023
FAX:
-353-1-663 6990
EMAIL:
emmet(a)andrews-introducer.com
NAME OF CONTACT PERSON: EMMET ANDREWS
DATE OF APPLICATION: SEPTEMBER 9, 2002
DEVICE DETAILS - ---------
ANDREWS INTRODUCER™ TRADE NAME:
COMMON NAME: SURGICAL FORCEPS
CLASSIFICATION NAME: FORCEPS, HTD.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED
-
- ROBERTS' FORCEPS
- TUBE INTRODUCTION FORCEPS
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DESCRIPTION OF THE DEVICE:
The Andrews Introducer™ is a reusable surgical forceps made of surgical steel that is specifically designed for the insertion of chest tubes. The Andrews Introducer™ is a three-limbed forceps and has three major features:
-
- A pivot joint at the fulcrum that opens the tips when the handles are closed using the stronger gripping force of the hand. The extent to which the tips open has been limited so as to reduce the trauma to the intercostal muscle.
-
- A vertical extension on each blade that creates a circular channel which is more accurately and appropriately shaped to allow easy passage of the chest tube. The distance between the vertical blades at the fulcrum is 10.7 millimetres, sufficient-to accommodate the diameter of a 32 gauge chest tube, expanding to 22mm at the.
-
- A third limb that is attached to the two main limbs through the pivot joint. It is held equidistant from the two main limbs by two leaf springs, which also close the tips when force is relieved from the handles. There is also a grip on the distal end of the third limb to hold the chest tube in position on the instrument for more rapid insertion once the channel has been created.
INTENDED USE OF THE DEVICE
INSERTION OF INTERCOSTAL CHEST TUBES -------
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Andrews Introducer™ are similar to those of the Roberts forceps in that they are both surgical forceps constructed of surgical steel and hinged on a pivot joint. The total length of the Andrews Introducer™ and the length of the section of the instrument that is inserted into the patient are similar to the Roberts forceps.
The additional technological characteristics of the Andrews Introducer™ are similar to the Tube Introduction forceps. They both contain a reverse pivot joint that opens the tips of the forceps when the handles are closed. A third arm is employed in each forceps to help guide the relevant tube into the dissected channel. A leaf spring is also used in the Tube Introduction forceps to maintain the forceps in the closed position.
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The Tube Introduction forceps also makes use of vertical extensions on each of the blades to create a more appropriately shaped channel for the tube being inserted.
SUBSTANTIAL EQUIVALENCE BASED ON CLINICAL PERFORMANCE DATA
A clinical feasibility study of the use of the Andrews Introducer™ in an elective surgical setting was undertaken. Chest tubes that were required as part of elective cardiothoracic operations, usually inserted using a Roberts forceps, were instead inserted-using the Andrews Introducer™. The primary end-point was successful and accurate placement of the chest tube. The operators also completed a questionnaire rating defined aspects of the procedure.
Thirty patients (19 male, 11 female; median age 61.5 years (range 16-81)) had chest tubes inserted using the Andrews Introducer™. The chest tube was inserted successfully without the trocar in all cases and there were no complications. Use of the Andrews Introducer™ rated as significantly easier relative to experience of use of the Roberts forceps in all specified aspects.
The Andrews Introducer™ can be used to insert intercostal chest drain safely and efficiently without using the trocar or any other instrument.
CONCLUSIONS
The Andrews Introducer™ is a reusable surgical forceps specifically designed for the insertion of chest tubes. It has been tested in a clinical trial. Substantial equivalence is claimed to the Roberts forceps, the forceps that is currently used for inserting chest drains, and the Tube Introduction forceps, a specifically designed forceps for the insertion of tubes into the trachea.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2002
Andrews Surgical Innovations, LTD. Emmet Andrews 16 Grove Lawn Malahide Co. Dublin Ireland
Re: K023173
Trade/Device Name: Andrews Introducer. Model ASI01 Regulation Number: 878.4800 Regulation Name: Manual surgical instrument Regulatory Class: Class I Product Code: MDM Dated: September 9, 2002 Received: September 23. 2002
Dear Mr. Andrews:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in
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Page 2 - Mr. Emmet Andrews
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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), 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 vours.
iriame C. Provost
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: Re: Product:
Model:
Andrews Introducer ASI01
INDICATION FOR USE FORM/STATEMENT
The Andrews Introducer™ is specifically designed for the insertion of intercostal chest tubes.
usiam C. Provost
Avision Sign-Off) Division of Gener o stive nd Neurological ﻚ ﺪ . . . . .
Furiber ... Ko 2 3173
Telephone: -353-87-239 2023.
§ 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.