(56 days)
The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.
The AMPLATZER™ TorqVue™ 45°x45° 80 cm Delivery Sheath (TV45x45 80cm) is an extension of the AMPLATZERTM TorqVue 45x45 Delivery Sheath (TV45x45 100cm) product family (K120120 and K083214) and is available in both a 12Fr and 14Fr sheath size.
The TV45x45 80cm is identical to the cleared TV45x45 (100cm) family of sheaths with the exception of having a shorter 80 cm length and the tip taper length of the 12Fr (80cm) dilator modeled on the taper length of the existing 14 Fr TV45x45 (100cm) dilator.
The 80 cm length is consistent with several TorqVue Delivery System products including the TorqVue™ Delivery system (ITV) cleared under submission K072313 and the TorqVue™ (TVLA) delivery sheaths cleared under submission K120120.
Similar to the predicate the TorqVue 45°x45° 80 cm Delivery Sheath includes a flush adapter, sheath and dilator. Figure 1 illustrates the delivery sheath and identifies the following essential components:
Sheath (A) -Catheter that enables device delivery by the physician. The body of the sheath is radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a radiopaque marker band near the distal tip.
Dilator (B) -Used to ease penetration of tissue and minimize vessel trauma during sheath insertion into and through the vasculature. For added visibility the dilator is radiopaque for visibility under fluoroscopy.
Flush Adaptor -The flush adaptor for both the 12F(C) and 14F (D) sheaths enables connection with syringes for flushing the sheath lumen.
The document provided is a 510(k) summary for a medical device (AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath). However, it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device. This document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for new medical devices in the US, rather than proving performance against specific acceptance criteria through a clinical or performance study with a test set, ground truth, and expert interpretations.
Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document as it pertains to a different type of regulatory submission.
Here's what can be gathered, largely in the context of a substantial equivalence claim:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or report specific performance metrics in the way an AI/ML device study would (e.g., sensitivity, specificity, accuracy). The "performance" demonstrated here is primarily through a comparison to a predicate device and functional/safety testing, asserting that the new device performs equivalently and safely.
| Acceptance Criteria (Implied based on Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use Equivalence: Device provides a pathway through which devices are introduced within the chambers of the heart, similar to predicates. | The AMPLATZER™ TorqVue™ 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart, identical to predicate devices. |
| Technological Characteristics Equivalence: Similar design, materials, and manufacturing processes to predicates. | "The AMPLATZER™ TorqVue™ 45°x45° 80cm subject device...shares the same design (with the exception of being 80cm length versus 100cm), materials, accessories, and manufacturing processes as the predicate." |
| Functional & Safety Equivalence: Performs safely and effectively, with previous design verification and validation testing supporting equivalence. | "The intended use, components, materials and fundamental design of the TV45x45 80 cm are identical to the cleared predicate TV45x45 (100cm) device...Design Verification and Design Validation testing have been previously performed and provided in cleared applications for the predicate device." |
| Minor Design Changes (Length, Dilator Tip): The changes in length and dilator tip taper are considered not to raise new questions of safety or effectiveness. | The device is 80 cm (vs. 100 cm) and the 12 Fr dilator has an extended tip taper length modeled on the 14 Fr predicate dilator. This change is explicitly mentioned and considered acceptable. |
2. Sample size used for the test set and the data provenance
Not applicable. This document does not describe a test set or data provenance in the context of evaluating an AI/ML algorithm. The equivalence is established through engineering and design comparisons, and prior testing of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is a traditional medical device submission, not an AI/ML device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there isn't a test set requiring expert consensus.
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 is not an AI/ML device, so no MRMC study or AI assistance evaluation was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document relies on regulatory standards, engineering principles, and prior verification/validation for predicate devices, rather than a "ground truth" in a clinical study sense for a novel diagnostic or AI device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
AGA Medical Corporation (wholly Owned By St. Jude Medical Co) Mary Johnson Regulatory Affairs Specialist I 5050 Nathan Lane Plymouth, Minnesota 55442
Re: K163000
Trade/Device Name: The AMPLATZER TorqVue 45° x 45° Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 29, 2016 Received: December 1, 2016
Dear Mary Johnson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163000
Device Name
AMPLATZER™ TorqVue™ 45° x45° Delivery Sheath
Indications for Use (Describe)
The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| 510(k) Number | K163000 |
|---|---|
| Submitter: | AGA Medical CorporationA wholly owned subsidiary of St. Jude Medical5050 Nathan LanePlymouth, MN |
| ContactPerson: | Mary Johnson,Regulatory Affairs Specialist IPhone: 651-756-2213Fax: 651-756-5744E-mail: mjohnson16@sjm.com |
| Date Prepared: | October 27, 2016 |
| Trade Name: | AMPLATZERTM TorqVueTM 45°x45° Delivery Sheath |
| CommonName: | Catheter Delivery System |
| Classification: | Class II, 21 CFR 870.1250Catheter, Percutaneous |
| Product Code: | DQY |
| PredicateDevice(s): | Primary Predicate-AMPLATZERTM TorqVueTM LA and AMPLATZER TorqVue45°x45° (14 Fr) Delivery Sheaths (K120120)Secondary Predicate-AMPLATZERTM TorqVueTM 45°x45° Delivery Sheath 9-13 Frsizes (K083214) |
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| DeviceDescription: | The AMPLATZER™ TorqVue™ 45°x45° 80 cm Delivery Sheath (TV45x45 80cm) isan extension of the AMPLATZERTM TorqVue 45x45 Delivery Sheath (TV45x45100cm) product family (K120120 and K083214) and is available in both a 12Fr and14Fr sheath size.The TV45x45 80cm is identical to the cleared TV45x45 (100cm) family of sheaths withthe exception of having a shorter 80 cm length and the tip taper length of the 12Fr(80cm) dilator modeled on the taper length of the existing 14 Fr TV45x45 (100cm)dilator.The 80 cm length is consistent with several TorqVue Delivery System productsincluding the TorqVue™ Delivery system (ITV) cleared under submission K072313 andthe TorqVue™ (TVLA) delivery sheaths cleared under submission K120120.Similar to the predicate the TorqVue 45°x45° 80 cm Delivery Sheath includes a flushadapter, sheath and dilator. Figure 1 illustrates the delivery sheath and identifies thefollowing essential components:Sheath (A) -Catheter that enables device delivery by the physician. The body of the sheath is radiopaque for visibility under fluoroscopy. For added visibility the sheath also has a radiopaque marker band near the distal tip. Dilator (B) -Used to ease penetration of tissue and minimize vessel trauma during sheath insertion into and through the vasculature. For added visibility the dilator is radiopaque for visibility under fluoroscopy. Flush Adaptor -The flush adaptor for both the 12F(C) and 14F (D) sheaths enables connection with syringes for flushing the sheath lumen.Figure 1. AMPLATZER TV 45x45 (80cm) ComponentsImage: [AMPLATZER TV 45x45 (80cm) Components] |
|---|---|
| Indications forUse: | The AMPLATZER™ TorqVue™ 45°x45° Delivery Sheath is intended to provide apathway through which devices are introduced within the chambers of the heart. |
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| Comparison to predicate: | AMPLATZER TM TorqVue 45°x45° (80cm) Delivery Sheath is an extension of theAMPLATZER TM TorqVue 45°x45° product family (K083214, K120120) line. | |||
|---|---|---|---|---|
| The AMPLATZER TM TorqVue 45°x45° 80cm subject device is available in either 12 or14Fr and shares the same design (with the exception of being 80cm length versus100cm), materials, accessories, and manufacturing processes as the predicate. Thedilator used with the 12 Fr subject device will be updated to have the same tip geometryas the predicate TV45x45 100cm 14 Fr device (the same dilator tip taper length and80cm length is also consistent with the marketed AMPLATZER TorqVue LA (TVLA1and TVLA 2) devices, K120120).Table 1 summarizes the changes being made to 12 and 14 Fr versions of the TV45x45 device. | ||||
| Table 1. TV45x45 Change Summary | ||||
| TV45x45 80 cm (Subject) | TV45x45 14Fr 100cm (Predicate-K120120) | TVLA 1&2 (Predicate-K120120) | ||
| Device Usable Length | 80 cm | 100 cm | 80 cm | |
| Tip Taper Length | Extended tip taper length | Extended tip taper length | Extended tip taper length | |
| 1The 14Fr size was cleared under K120120; the remaining Fr sizes in the TV45x45 family were cleared earlier under K083214. | ||||
| Functional and Safety Testing: | The intended use, components, materials and fundamental design of the TV45x45 80 cm are identical to the cleared predicate TV45x45 (100cm) device (TV45x45 device family cleared in two submissions K083214 and K120120). Design Verification and Design Validation testing have been previously performed and provided in cleared applications for the predicate device (TV 45x45 (100 cm, K120120 and K083214), TVLA1 and TVLA 2 Delivery Sheath (K120120) devices). Separate packaging design verification has been completed on the subject device. | |||
| Conclusion: | AGA/SJM considers the TorqVue 45°x45° 80 cm Delivery Sheath to be substantially equivalent to the TorqVue 45°x45° 100 cm Delivery Sheath. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. The devices are identical with the exception of a length and dilator tip angle change. |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).