(14 days)
The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.
The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".
The provided text describes a 510(k) submission for HI-TORQUE Guide Wires, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a novel device requiring extensive performance acceptance criteria and a dedicated study to prove those criteria.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state formal quantitative acceptance criteria for the expanded indication. Instead, it relies on demonstrating equivalence to predicate devices and showing acceptable performance in in vivo animal and human clinical studies for the specific new intended use (placement of coronary venous pace/sense leads).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Animal Study) | Acceptable performance within the coronary vein when used with a compatible lead system. |
| Safety (Human Study) | Safe for use in placing a compatible coronary venous pace/sense lead in the coronary venous vasculature. |
| Effectiveness (Human Study) | Effective for use in placing a compatible coronary venous pace/sense lead in the coronary venous vasculature. |
| Substantial Equivalence | The HI-TORQUE Guide Wires with the expanded indication are substantially equivalent to the currently marketed HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire (K983033) with regard to intended use. All other aspects are identical to previously cleared guide wires. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Animal Study: The sample size is not specified. The text only mentions "Animal studies were conducted." Data provenance is not specified, but typically animal studies for medical devices are conducted in controlled environments.
- Human Clinical Testing Data: The sample size is not specified. The text states, "HI-TORQUE Guide Wires were evaluated in a clinical investigation." The data provenance is not specified, but it was a clinical investigation, implying a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. Given that this is a 510(k) for an expanded indication and not a de novo device, the focus is on safety and effectiveness as demonstrated through the in vivo studies, rather than a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. As explained above, the nature of this submission (expanded indication for a guide wire) does not typically involve a complex adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might. The evaluation likely focused on procedural success, adverse events, and device performance metrics.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the HI-TORQUE Guide Wire is. The device is a physical medical instrument whose performance is assessed through its direct application in procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. The HI-TORQUE Guide Wire is a physical medical device, not a software algorithm. Its performance is intrinsically linked to its use by a human operator (e.g., a cardiologist).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the human clinical testing, the "ground truth" would likely be successful placement of the compatible coronary venous pace/sense lead and absence of significant adverse events. This would be determined by the treating physician and potentially confirmed through post-procedure imaging or clinical follow-up (outcomes data related to the procedure's success and safety).
8. The sample size for the training set
The concept of a "training set" is not applicable to this device. Training sets are used in machine learning for AI algorithms. This submission concerns a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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KQ/a85
MAY 0 2 2002
510(k) Summary
- Device Name: HI-TORQUE Guide Wire -
- HI-TORQUE BALANCED MIDDLEWEIGHT (BMW), Model 6720 .
- HI-TORQUE BALANCED HEAVYWEIGHT (BHW), Model 6722 .
- HI-TORQUE BALANCED TREK, Model 6723 ●
- HI-TOROUE EXTRA S'PORT, Model 6724 .
- HI-TOROUE IRON MAN, Model 6725 .
- HI-TORQUE WHISPER LS, Model 6726
- HI-TOROUE WHISPER MS, Model 6737
- Devices to Which Equivalence is Claimed: HI-TORQUE BALANCED MIDDLEWEIGHT (K983033, cleared 11/10/98) with regard to intended use and all other aspects of the proposed HI-TORQUE Guide Wires are identical to the currently marketed Guide Wires (K950156, cleared 4/5/95; K963702, cleared 1/22/97; K982083, cleared 9/11/98; K983033, cleared 11/10/98; K991152, cleared 4/29/99; and K002206, cleared 8/24/00).
-
- Intended Use: The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic .
منزلوبر سرور سر
منزل المنتدى and/or therapeutic procedures.
- 4. Device Description: The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".
-
- Summary of Technological Characteristics: This notification concerns a labeling modification to expand the indications for currently marketed devices. There are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject devices.
-
- Summary of Substantial Equivalence: This notification concerns a labeling modification to expand the indications for the currently marketed device. The indications are equivalent to the currently marketed HI-TORQUE BALANCED MIDDLEWEIGHT (K983033, cleared 11/10/98). All other aspects of the proposed Guide Wires are identical to the currently marketed Guide Wires (K950156, cleared 4/5/95; K963702, cleared 1/22/97; K982083. cleared 9/11/98; K983033. cleared 1 11/10/98; K991152, cleared 4/29/99; and K002206, cleared 8/24/00).
7. Testing Data:
In Vivo Testing
Animal studies were conducted to evaluate the performance of the HI-TORQUE Guide Wires when the devices were used within the coronary vein. The results of the
510(k) Submission for Guidant HI-TORQUE Guide Wires Guidant/CRM - March, 2001
Page 10 of 11
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in vivo animal evaluation showed that the Hi-Torque Guide Wires are acceptable within the coronary vein when used with a compatible lead system.
Human Clinical Testing Data:
HI-TORQUE Guide Wires were evaluated in a clinical investigation. The function of the HI-TOROUE Guide Wire in this clinical investigation was to aid in the placement of a coronary venous pace/sense lead in the coronary venous vasculature. The results demonstrated that the HI-TORQUE Guide Wires are safe and effective for use in placing a compatible coronary venous pace/sense lead in the coronary venous vasculature.
Conclusion: The HI-TORQUE Guide Wires with the expanded indication are substantially equivalent to the currently marketed HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire (K983033, cleared 11/10/98) with regard to intended use. All other aspects of the proposed HI-TORQUE Guide Wires are identical to the currently marketed Guide Wires (K950156, cleared 4/5/95; K963702; cleared 1/22/97; K982083, cleared 9/11/98; K983033, cleared 11/10/98; K991152, cleared 4/29/99; and K002206, cleared 8/24/00).
510(k) Submission for Guidant HI-TORQUE Guide Wires Guidant/CRM - March, 2001
Page 11 of 11
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
MAY - 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Karen S. Alsop Pr. Regulatory Affairs Associate Guidant Corporation 4100 Hamline Avenue N St. Paul. MN 55112
Re: K021282
Trade Name: LV-1 Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold fitting Regulatory Class: Class II (two) Product Code: DTL
Re: K021283
Trade Name: Guidant Balloon Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO
Re: K021284
Trade Name: EASYTRAK® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY
Re: K021285
Trade Name: HI-TORQUE® Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 17, 2002 Received: April 18, 2002
Dear Ms. Alsop:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your bootion 910(t) probstantially equivalent (for the indications for use stated in the enclosures) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, onolood 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 approvial of a provisions of the Act. The general controls provisions of the Act include
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Page 2 - Ms. Karen S. Alsop
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 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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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.
DaStiller
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Kod 1285
Device Name: HI-TORQUE®BALANCE MIDDLEWEIGHT™ Guide Wire HI-TORQUE EXTRA S'PORT™ Guide Wire HI-TORQUE IRON MANTM Guide Wire HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire HI-TORQUE BALANCE TREK™ Guide Wire HI-TORQUE WHISPER™ LS and MS Guide Wires
Indications for Use:
The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter _ (Optional Format 1-1-96)
MegacMginsh
for Donna-Bea Tillman
of Cardiovascular & Respiratory Devic
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.