(25 days)
To facilitate the placement of devices during diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
Nickel Titanium steerable core with a clear or colored, radiopaque jacket, with a polymer/ hydrophilic coating is applied over the core/jacket. The guidewires are bound by the following parameters: Outside Diameter: .018" - .038", Lengths: 150 cm - 400 cm, Tips: Straight or shaped with standard or long taper tip flexibility. Note: None of these guidewires are for PTCA use.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: LRM Hydrophilic Coated Guidewire
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the document describes tests conducted to demonstrate equivalence to a predicate device (Terumo guidewires) and ensure product quality. The reported performance is generally stated as "All test results were within prescribed specification limits" for engineering specifications, and specific qualitative findings for biocompatibility.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Engineering Specifications (Implied to be equivalent to predicate and within internal design criteria): - Visual appearance (polymer tip integrity, jacket durability) - Dimensional Measurement (Outside Diameter, Dry, after 10 min soak, after 40 min soak) - Lubricity (force required to insert/withdraw in catheter) - Pull Test (strength of welded joint points) - 3-Point Bending Test (body stiffness/flexibility) - Coating Durability (lubricity after multiple catheter insertions/withdrawals) - Distal Tip (J) Memory (memory of shaped product) - Kink Resistance - Linear Stiffness (linear tip flexibility) - Torque Control (response and rotational control) - Torque Fatigue (torqueable strength) | Engineering Specifications: "All test results were within prescribed specification limits." (Implies meeting the design criteria and demonstrating equivalence to the predicate). |
| Biocompatibility Testing (Meeting recommendations in FDA's General Program Memorandum #G95-1 and ISO-10993): - Acute Systemic Toxicity - Cytotoxicity (MEM) - Hemolysis - Intracutaneous Test - Pyrogen (Material Mediated) - Inhibition and Enhancement - Sensitization - Thrombo In-Vitro (Plate Method) | Biocompatibility Testing: - Acute Systemic Toxicity: "No signs or symptoms of Systemic Toxicity were observed for any of the samples." - Cytotoxicity (MEM): "The samples evoked a mild cytotoxic response (Grade 1), when tested at 48 hours. The test material passed the assay." - Hemolysis: "The samples did not produce hemolysis." - Intracutaneous Test: "For all samples, skin reactions were not significant." - Pyrogen (Material Mediated): "The samples did not produce a pyrogenic response." - Inhibition and Enhancement: "No endotoxin detected at 0.03 eu/ml." - Sensitization: "The samples were deemed to be a non-sensitizer." - Thrombo In-Vitro (Plate Method): "The test article was considered non-thrombogenic." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For each test series within the comparative test data, either fifteen (15) or ten (10) test samples were selected. Some destructive tests required additional sets of 10 or 15 samples. This applied to each of the three groups of wires (.018", .035", .038" standard configurations, including straight and shaped distal tips).
- Data Provenance:
- Country of Origin: Not explicitly stated, but Lake Region Manufacturing, Inc. is located in Chaska, MN, USA. The "Terumo product was purchased by LRM, complete in packaging," so the Terumo product could have originated from anywhere Terumo manufactures.
- Retrospective or Prospective: Prospective. The test samples were "produced following current manufacturing processes and procedures," and "Terumo product was purchased." "All samples were sterilized prior to testing." This indicates newly manufactured products specifically for this comparative testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" establishing ground truth in the traditional sense of clinical opinion or image interpretation. The "ground truth" for these engineering and biocompatibility tests is based on objective, quantitative measurements against predefined internal design specifications and recognized standards (e.g., ISO-10993) or established test methodologies.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements (e.g., micrometer measurements, force measurements, chemical assays). There is no subjective assessment requiring adjudication.
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
Not applicable. This submission is for a medical device (guidewire), not an AI-powered diagnostic or interpretive tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications: Internal design criteria/specifications (presumably quantitative engineering limits) and a comparison to a predicate device (Terumo guidewires) presumed to be safe and effective.
- Biocompatibility: Recommendations from FDA's General Program Memorandum #G95-1 and international standard ISO-10993 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing), which specify acceptable biological responses to materials. These are based on established scientific principles and regulatory guidance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set. The "training" for the device itself would be the manufacturing process and quality system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of a physical medical device. The "ground truth" for ensuring consistent manufacturing would be the established "current manufacturing processes and procedures" and "design specifications" mentioned in the document, which are part of LRM's formal quality systems.
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JUN 5 1998
SECTION 2.0 - SUMMARY & CERTIFICATION
P, o73
-
- İ General Information
- Company Name, Address, and Telephone Number 2.1.1
Lake Region Manufacturing, Inc., (LRM) 340 Lake Hazeltine Drive Chaska, MN 55318
Fax: (612) 448-3441 Telephone: (612) 448-5111
-
2.1.2 Device Trade Name/Proprietary Name
LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission. -
2.1.3 Device Common Names/Usual Names, and Classification Names
These devices are commonly known as guides, guidewires, or spring guidewires. The current classification name, and product code is Gastroenterology-Urology Catheter Accessory (78KOD). -
2.1.4 LRM Establishment Registration Number: 2126666
- Class of Device 2.1.5
This type of guidewire was originally listed as Class II devices by the Gastroenterology-Urology Review Panel (21CFR 876.5130).
-
2.1.6 Applicability of Performance Standards
LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards. -
2.2 Labels, Labeling, and Advertising
LRM produces cardiovascular and vascular guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. Changes to the customer controlled labels, labeling, or promotional material are at their discretion, including the resolution of any resulting regulatory obligations. A small fraction of the total production bears LRM controlled labels and labeling.
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K98/667
P2093
2.3 Summary of Safety and Effectiveness
This summary is being included in the Premarket Notification submission in lieu of a statement of availabilitv.
- 2.4 Device Description
- 2.4.1 Description of Guidewire
Nickel Titanium steerable core with a clear or colored, radiopaque jacket, with a polymer/ hydrophilic coating is applied over the core/jacket. The guidewires are bound by the following parameters:
| Outside Diameter: | .018" - .038" |
|---|---|
| Lengths: | 150 cm - 400 cm |
| Tips: | Straight or shaped with standard or long taper tip flexibility |
Note: None of these guidewires are for PTCA use.
-
2.4.2 Engineering Specifications
The design specifications are the same for guidewires manufactured with or without the polymer/ hydrophilic coating. The finished devices must meet the same design criteria. Section 2.5 contains comparative data to demonstrate equivalency. -
2.5 Substantial Equivalence Data
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5.1 Background Information
In order to demonstrate equivalence of guidewires manufactured with polymer/hydrophilic, LRM performed comparative testing between LRM hydrophilic guidewires and Terumo guidewires.
LRM chose a product mix of three groups of wires, based on the available Terumo products of .018", .035" and .038" standard configurations, including straight and shaped distal tips. LRM samples were produced following current manufacturing processes and procedures. Terumo product was purchased by LRM, complete in packaging. All samples were sterilized prior to testing.
2.5.2 Comparative Test Data
Within each of the three groups, production samples were made representing the minimum (smallest size), maximum (largest size) and mode (most common size). For each test series, samples were produced per standard manufacturing procedures. For each test type, either fifteen (15) or ten (10) test samples were selected. Some of the tests are destructive in nature which required the selection of additional sets of fifteen (15) or ten (10) samples to perform other tests.
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The following product qualification tests were performed:
- Visual: Assess the visual appearance of the product for polymer tip integrity and jacket 2.5.2.1 durability (cuts, splits, seams, etc., any indication that the tip has been compromised).
- Dimensional Measurement Outside Diameter, Dry and after 10 minutes soak 2.5.2.2 and after 40 minute soak in normal saline : Micrometer measurement of the outside diameter of the guidewire at multiple body points.
- Lubricity: Measures the force required to insert and withdraw the guidewire 2.5.2.3 within a catheter lumen standardized to each guidewire diameter.
- 2.5.2.4 Pull Test: Measures the strength of welded joint points in the guidewire.
- 2.5.2.5 3-Point Bending Test: Assess guidewire body stiffness/flexibility.
- Coating Durability: Measures the lubricity before and after multiple catheter 2.5.2.6 insertions and withdrawals.
- 2.5.2.7 Distal Tip(J) Memory: Assess the memory of the distal tip form of shaped product.
- 2.5.2.8 Kink Resistance: Measures the kink resistance properties of product made from kink resistance materials or products that are designed to have kink resistance properties.
- 2.5.2.9 Linear Stiffness: Measures the linear tip flexibility.
- 2.5.2.10 Torque Control: Assess guidewire torque response and rotational control to allow placement of the distal tip at a desired location in a 360 degree circle when controlled from the proximal end of the guidewire. Control may be clockwise or counter -clockwise.
- 2.5.2.11 Torque Fatigue: Assess the torqueable strength of a guidewire.
RESULTS: All test resuits were within prescribed specification limits.
- 2.6 Qualification and Biocompatibility Test Data
- 2.6.1 Material/Product/Process Qualifications
LRM has formal quality systems in place to assure that each product manufactured with the polymer/hydrophilic coating remain equivalent to the predicate product, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.
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12981667 P3073
Biocompatibility Testing 2.6.2
LRM has adapted the biocompatibility testing recommendations in the FDA's General Program Memorandum #G95-1 Use of international Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", dated May 1, 1995.
The following table lists the test that were performed and the test results.
| TEST PERFORMED | TEST RESULTS |
|---|---|
| Acute Systemic Toxicity | No signs or symptoms of Systemic Toxicity wereobserved for any of the samples. |
| Cytotoxicity (MEM) | The samples evoked a mild cytotoxic response(Grade 1), when tested at 48 hours. The testmaterial passed the assay. |
| Hemolysis | The samples did not produce hemolysis. |
| Intracutaneous Test | For all samples, skin reactions were notsignificant. |
| Pyrogen (Material Mediated) | The samples did not produce a pyrogenicresponse. |
| Inhibition and Enhancement | No endotoxin detected at 0.03 eu/ml |
| Sensitization | The samples were deemed to be a non-sensitizer. |
| Thrombo In-Vitro (Plate Method) | The test article was considered nonthrombogenic |
2.7 Packaging and Sterilization Information
LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. A small portion of the production is private label, single packaged to customer specifications, a fraction of that product provided sterile to the customer.
The single packaged polymer/hydrophilic coated guidewires s placed in a dispenser and then into a Tyvek/poly pouch, along with a tray containing a torque device. The product may be packaged as five pouches in a shelf carton (five pack), which is a typical packaging configuration.
There will be no changes to the sterilization process for the portion of packaged product shipped sterile to the customer. For the product that is shipped bulk, the packaging design and sterilization process parameters are the customer's responsibility. LRM will not recommend that its customers modify their packaging or sterilization procedures as a result of this submission.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name in a circular arrangement and a stylized symbol. The text "DEPARTMENT OF HEALTH & HUM." is visible along the upper arc of the circle. To the right of the text is a symbol composed of three abstract human profiles facing right, stacked one above the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1098
Ms. Kim E. Aves Regulatory Compliance Manager Lake Region Manufacturing, Inc. 340 Lake Hazeltine Drive Chaska, MN 55318
Re: K981667 LRM Hydrophilic Coated Guidewire Dated: May 8, 1998 Received: May 11, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 KNY
Dear Ms. Aves:
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 III (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 Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 i 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the provincion 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/cdrb/dsmaldsmam.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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510(k) Number (if known): Unknown
Device Name: Hydrophilic Coated Guidewire
Indications for Use:
To facilitate the placement of devices during diagnostic and interventional procedures.
NOTE: These guidewires are not intended for PTCA use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Rathbun/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981667
Prescription Use X Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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 § 876.9.