(168 days)
A catheter tunneler is indicated whenever a surgeon would like to create a minimally invasive subcutaneous path for an implanted catheter. The implanting surgeon would oftentimes utilize the tunneler when implanting our TrimPort Systems. Our TrimPort Systems are indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
Gerard Medical plans to manufacture and market a catheter tunneler. This device will be used to create a subcutaneous path for an intraluminal catheter. The design of the device is such that the distal tip can separate subcutaneous tissues when manual force is applied in the direction of the tip along the length of the device proximal to the tip. The device has a means to connect the catheter in order to draw it through the subcutaneous tunnel. The tunneler may be constructed of any material (eg. metal or plastic) which permits separation of, and passage through, subcutaneous layers and is suitable for contact with this tissue. The initial device that we plan to produce and market is made of the plastic Delrin 500. We may, at a later date, provide an additional model that would consist of a medical grade stainless steel.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Catheter Tunneler:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|
| Test #1: Force Resistance | |
| Device must withstand 5 pounds of force when distal end is abutted against an immovable flat surface. | The device is manufactured to meet this specification, implying it consistently withstands 5 pounds of force. |
| Test #2: Catheter Connection Tension | |
| Catheter must remain connected to the proximal end when subjected to 2 pounds of tension, both linearly and at a 45-degree angle. | The device is manufactured to meet this specification, implying the catheter remains securely connected under 2 pounds of tension (linear and at 45 degrees). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states, "we will mandate that the following tests be performed for the appropriate percentage of our finished devices prior to their being released for usage." It does not specify an exact number or "percentage" of devices that will be tested. This implies an ongoing quality control process rather than a one-time validation study with a fixed set.
- Data Provenance: The tests are described as part of the "Manufacturing Specification" and are performed on "finished devices prior to their being released for usage." This indicates the data is prospective as it's part of the manufacturing and release process. There is no information about the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This type of device (a mechanical surgical tool) does not involve expert interpretation or subjective evaluation for its primary acceptance criteria. The criteria are purely mechanical benchmarks (force and tension).
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication is typically used for subjective assessments (e.g., medical image interpretation). The tests described are objective, pass/fail mechanical tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not relevant for this type of device. There is no "reader" (human interpreter) or "AI assistance" being evaluated in the context of device performance. The device is a standalone surgical tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, implied. The described tests are for the device's standalone mechanical performance, without human "in-the-loop" interaction for meeting the acceptance criteria. The performance is solely based on whether the device itself can withstand the specified forces and maintain catheter connection. While a human applies the force for the test, the test result is about the device's inherent capability, not a human's performance using the device.
7. Type of Ground Truth Used:
- Mechanical Stress/Strength Thresholds. The ground truth is established by predetermined, objective mechanical thresholds (5 pounds of force, 2 pounds of tension) that the device must meet or exceed. These thresholds were determined based on "bench testing" which indicated they are "significantly higher than would be anticipated during the actual surgical procedure."
8. Sample Size for the Training Set:
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of algorithm development. The "bench testing" mentioned in the document likely referred to early prototype testing and design validation to determine the appropriate stress levels for the acceptance criteria, but not a dataset for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, this question is not applicable. The "ground truth" for the acceptance criteria (the force and tension values) was established through internal "bench testing" and engineering evaluation to ensure the device could withstand stresses "significantly higher than would be anticipated during the actual surgical procedure."
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1972554 Docember 22, 1997
Summary of Safety and Effectiveness Information: 2a. & 2d.
Gerard Medical, Inc. Company Name and Address: 6 City Depot Rd. P.O. Box 940 Charlton City, MA 01508
Company Telephone No.: (508) 248-1562
Richard Cayer, Jr. Company Contact Name:
September 24, 1997 Summary Date:
Catheter Tunneler Proprietary Name:
Tunneler (accessory to catheter or Common or Usual Name: implanted vascular access system)
Surgical Tunneler Classification Name:
Class: Unclassified
Legally Marketed Substantially Bquivalent Device:
Manufactured by Bard Access Systems Catheter Tunneler. (Division of C.R. Bard, Inc. )
Device Description and Intended Usage:
Gerard Medical plans to manufacture and market a catheter This device will be used to create a subcutaneous path tunneler. The design of the device is such for an intraluminal catheter. that the distal tip can separate subcutaneous tissues when manual force is applied in the direction of the tip along the length of The device has a means to the device proximal to the tip. connect the catheter in order to draw it through the subcutaneous The tunneler may be constructed of any material tunnel. (eg. metal or plastic) which permits separation of, and passage through, subcutaneous layers and is suitable for contact with The initial device that we plan to produce and this tissue. market is made of the plastic Delrin 500. We may, at a later date, provide an additional model that would consist of a medical grade stainless steel.
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Summary of Safety and Effectiveness Information 2a. & 2d. (continued):
When utilized during a surgical procedure, the tunneler must be able to withstand the force applied to create the subcutaneous Also, during this procedure, the catheter must remain path. connected to the distal end of the device.
As part of the Manufacturing Specification that we are creating for this device, we will mandate that the following tests be performed for the appropriate percentage of our finished devices prior to their being released for usage.
Test #1:
With the distal end (i.e. front end) of the device squarely abutted against an immovable flat surface, a 5 pounds force test will be performed.
Test #2:
With a catheter connected to the proximal end (i.e. back end) of the device, a 2 pound tension test will be performed. For this test the catheter will be pulled in two directions, both linearly (i.e. straight) and at a 45 degree angle.
Note that, based on our bench testing, the above levels of stress are significantly higher than would be anticipated during the actual surgical procedure.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Cayer, Jr. ·President Gerald Medical, Incorporated 6 City Depot Road P.O. Box 940 01508 Charlton, Massachusetts
DEC 22 1997
K972555 Re : Catheter Tunneler Trade Name: Requlatory Class: Unclassified Product Code: 1.35 Dated: September 24, 1997 September 29, 1997 Received:
Dear Mr. Cayer:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
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Page 2 - Mr. Cayer
through 542 of the Act for devices under the Electronic
and the Man Castmal provisions, or other Federal 1 through 542 of the Act for devices under the 2000-11-11
Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as the FDA This letter will allow you co begin additions. The FDA described in your 510(K) premarker not revice to a legally
finding of substantial equivalence of your device to your finding of substantial equivatence or your sification for your marketed predicate device results in a crabbission and the market.
If you desire specific advice for your device on our labeling
and and the CER Box 201 and additionally 809.10 for in If you desire specific advice for your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CM Pat bor bor and contact the Office of
vitro diagnostic devices), please contact the Office of yitro diagnostic devices), prease concass of for questions on
Compliance at (301) 594-4618. Additionally, for quease contact Compliance at (301) 594-4616. Addrise, please contact
the promotion and advertising of your device, please not the promotion and advertualing of your design. Also, please note
the Office of Compliated at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 800mm . Other gener the Act ma Other general premarket notification on your responsibilities under the Act may be information on your responsibilities ands- turers Assistance obtained from the Division of Smart Manuzacoan 443-6597 or at
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (800) 638-2041 of (302) 2007-10-11 (1)
its internet address "http://www.fda.gov/cdrh/damamain.html".
sincerely yours,
Alatros
Klatowski
Ulatowski Timoth Director Director and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10(k) Number (if known): _ 14 9 7 2 5 5 5 5
Catheter Tunneler evice Name:___________________________________________________________________________________________________________________________________________________________________
ndications For Use:
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A catheter tunneler is indicated whenever a surgeon would like to create a minimally invasive subcutaneous path for an implanted The implanting surgeon would oftentimes utilize the catheter. tunneler when implanting our TrimPort Systems. Our TrimPort Tunneler when implantang one indicated whenever patient therapy implancable reseated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
not o 510(k) N
rescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”