(283 days)
The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.
The T-SPeCTM Surgical System is, in effect, a sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument used to create a cystostomy and place the suprapubic catheter; and c) a piston syringe to fill the catheter balloon after placement.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Basis for Substantial Equivalence | To demonstrate that T-SPeC™ Surgical System is as safe and effective as legally marketed predicates. | The submission claims the device is "substantially equivalent" to predicate devices, asserting that its modified technological characteristics "do not adversely affect the safety and effectiveness of the subject device" based on non-clinical bench studies. |
| Suprapubic Catheter Design & Performance | No specific quantitative acceptance criteria are provided in the summary. Implies qualitative comparison to predicates for design and performance. | "various bench performance studies have been performed related to: • Suprapubic Catheter design and performance." (No specific results or parameters are presented in the summary.) |
| Catheter Accessory Design & Performance | No specific quantitative acceptance criteria are provided in the summary. Implies qualitative comparison to predicates for design and performance. | "various bench performance studies have been performed related to: • Catheter accessory design and performance." (No specific results or parameters are presented in the summary.) |
| Biocompatibility | To ensure the device materials are safe for human contact. | "various bench performance studies have been performed related to: • Biocompatibility." (No specific results, tests, or standards are presented in the summary.) |
| Sterilization Validation & Shelf Life | To ensure the device is sterile and maintains its integrity over its intended shelf life. | "various bench performance studies have been performed related to: • Sterilization Validation & Shelf Life." (No specific results or parameters are presented in the summary.) |
A critical point to note is the absence of specific, quantitative acceptance criteria and their corresponding reported performance values within this 510(k) summary. The summary states that "various bench performance studies have been performed" but does not detail the specific criteria or the results of those studies. The primary "acceptance criterion" articulated is the demonstration of "substantial equivalence" to predicate devices based on non-clinical data.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a "test set" in the context of clinical or performance data for an AI/algorithm-based device.
- Sample Size for Test Set: Not applicable as no clinical or AI-specific performance testing is detailed.
- Data Provenance: Not applicable. The submission explicitly states, "No clinical performance testing was performed." The equivalence is based on non-clinical bench studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. As no clinical performance testing or "test set" requiring expert ground truth was conducted, no experts were used for this purpose.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since no clinical performance testing requiring a "test set" with expert review was conducted, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. The provided text does not mention any MRMC comparative effectiveness study. This is not an AI/software as a medical device (SaMD) submission where such studies would be typical.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. The device is a "Surgical System" consisting of physical medical instruments (catheter, punch instrument, syringe), not a standalone algorithm or software. Therefore, the concept of "algorithm only" performance is not relevant to this submission.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of clinical or AI performance. The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science, and performance testing benchmarks for similar physical medical devices (e.g., integrity of materials, sterility, functionality of mechanical components). The "ground truth" is essentially conformance to design specifications and recognized standards for physical medical devices, as demonstrated by bench testing.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a physical device.
Summary of the Study:
The study proving the device meets its "acceptance criteria" (which in this case is primarily substantial equivalence to predicate devices for safety and effectiveness) consists of non-clinical bench performance studies.
The 510(k) summary explicitly states: "No clinical performance testing was performed. Substantial equivalence for the subject device is based on the aforementioned non-clinical bench studies."
These bench studies covered:
- Suprapubic Catheter design and performance.
- Catheter accessory design and performance.
- Biocompatibility.
- Sterilization Validation & Shelf Life.
The detailed results and specific acceptance parameters of these bench studies are not provided in the 510(k) summary (which is common for these summaries). The FDA's decision to clear the device implies that the non-clinical data was sufficient to demonstrate substantial equivalence to legally marketed predicate devices for the stated intended use.
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SWAN VALLEY MEDICAL
INCORPORATED
OCT 26 2012
510(k) SUMMARY
Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System
Submitter Information I.
Swan Valley Medical, Incorporated 510(k) Owner: Harbor Village 301 Eagle Bend Drive P.O. Box 3005 Bigfork, MT 59911 USA
Mr. Ronald E. Zook, President and CEO Sponsor Contact: 406-837-1500 (office) 406-837-1532 (fax)
Submission Correspondent / Consultant:
Kevin Randall, Principal Consultant ComplianceAcuity, Inc. 16576 W. 5310 Way Golden, CO 80403 (303) 828-0844 (direct) (303) 828-0835 (fax) Email: info@complianceacuity.com
Date Summary Prepared:
January 16, 2012
Name of Device II.
Swan Valley Medical Transurethral Suprapubic Trade Name: endo-Cystostomy (T-SPeCTM) Surgical System Suprapubic Catheter and Accessories Common/Usual Name: Suprapubic urological catheter and accessories Classification Name: (21 CFR 876.5090, Product Code KOB)
510(k) Summary page 1 of 4
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SWAN
510(k) SUMMARY
Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System
III. Device Description
The T-SPeCTM Surgical System is, in effect, a sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument used to create a cystostomy and place the suprapubic catheter; and c) a piston syringe to fill the catheter balloon after placement. As provided and configured in this kit, none of these constituents are legally marketed devices. Therefore each constituent is itemized in this section 510(k) notification.
IV. Intended Use
The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage.
Identification of / Comparison to Legally Marketed Predicates V.
The predicate devices to which substantial equivalence is being claimed are tabulated below:
| Predicate Device | Manufacturer | 510(k) | Relevance |
|---|---|---|---|
| Fortune SuprapubicCatheter | Fortune MedicalInstrument Corp. | K014002 | T-SPeCTM Suprapubic Catheter intended for bladder drainage. |
510(k) Summary page 2 of 4
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Image /page/2/Picture/0 description: The image shows the logo for Swan Valley Medical Incorporated. The logo consists of the text "SWAN VALLEY MEDICAL" in bold, uppercase letters, with the word "INCORPORATED" in smaller letters underneath. To the right of the text is a vertical line, followed by a drawing of a swan in flight.
510(k) SUMMARY
Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System
| Predicate Device | Manufacturer | 510(k) | Relevance |
|---|---|---|---|
| Lowsley SuprapubicTractor | Circon Corp.(now owned byGyrus ACMI, Inc.) | K012153 | T-SPECTTM Catheter PunchInstrument:• “inside-out” cystostomyvia transurethral bladderaccess• Capture and placementof Suprapubic Catheter |
| QlicksmartBladeFLASK andBladeSINGLE | Qlicksmart Pty.,Ltd. | K983367 | Sharps containment feature ofthe T-SPECTTM Catheter PunchInstrument. |
| Omnifix® Syringe | B. Braun MedicalInc. | K071459 | T-SPECTTM Piston Syringe forinflating/deflating catheterballoon |
Each component of the T-SPeC™ Surgical System was compared to the corresponding predicate based on various design and performance factors.
Summary of Non-Clinical Performance Data VII.
To support the substantial equivalence claim made herein, various bench performance studies have been performed related to:
| • Suprapubic Catheter design and performance. | • Biocompatibility |
|---|---|
| • Catheter accessory design and performance. | • Sterilization Validation & Shelf Life |
510(k) Summary page 3 of 4
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SWAN VALLEY INCORP
510(k) SUMMARY
Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System
VIII. Summary of Clinical Performance Data
No clinical performance testing was performed. Substantial equivalence for the subject device is based on the aforementioned non-clinical bench studies.
Conclusions Drawn IX.
As demonstrated by the predicate device comparisons herein, The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeCTM) Surgical System has the same intended use as the legally marketed predicates but incorporates different technological characteristics. Nevertheless, the performance data submitted in support of this section 510(k) Notification demonstrate that the modified technological characteristics do not adversely affect the safety and effectiveness of the subject device. Based on these facts, it is therefore the conclusion of Swan Valley Medical Incorporated that the subject device is as safe and as effective, that is, "substantially equivalent" to, the predicates pursuant to section 513(i) of the Act.
END OF 510(k) SUMMARY
510(k) Summary page 4 of 4
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
OCT 26 2012
Swan Valley Medical, Incorporated % Mr. Kevin Randall Principal Consultant ComplianceAcuity, Inc. 16576 W. 53td Way GOLDEN CO 80403
Re: K120127
Trade/Device Name: Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System
Regulation Number: 21 CFR§ 876.5090
Regulation Name: Suprapubic urological catheter and accessories of Regulatory Class: II Product Code: KOB, FEX Dated: October 11, 2012 Received: October 12, 2012
Dear Mr. Randall:
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.
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Page 2 – Mr. Kevin Randall
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
formi marly
Benjamin R. Fisher, Ph.D. & Benjami Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120127
Device Name:
Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System
Indications For Use:
The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hra Mz
Division of Reproductive, Gastro-Renal, and Urological Device K120127 510(k) Number A-1
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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.