K Number
K120127
Device Name
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
Date Cleared
2012-10-26

(283 days)

Product Code
Regulation Number
876.5090
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The 510(k) summary describes a mechanical surgical system for suprapubic catheterization and drainage, with no mention of AI or ML in the intended use, device description, or performance studies.

No
The device is described as a surgical system for suprapubic bladder catheterization and drainage, which is a supportive and facilitative procedure rather than directly treating a disease or condition for therapeutic purposes.

No

The device is described as a "Surgical System" intended for "suprapubic bladder catheterization (cystostomy) and drainage," indicating a therapeutic and interventional purpose rather than a diagnostic one.

No

The device description explicitly states it is a "sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument; and c) a piston syringe." These are all physical hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "suprapubic bladder catheterization (cystostomy) and drainage." This is a surgical procedure performed directly on the patient's body for therapeutic purposes (drainage).
  • Device Description: The device is a "sterile suprapubic catheter and accessory kit" used to perform this surgical procedure.
  • Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. There is no mention of this device being used for testing specimens.
  • Clinical Performance Data: The summary of performance studies mentions "Non-Clinical Performance Data" and "No clinical performance testing was performed." While this doesn't definitively rule out IVD status, it aligns with a device used for a surgical procedure rather than diagnostic testing.

In summary, the device is a surgical tool used for a therapeutic procedure on a patient, not for testing specimens in a laboratory setting.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KOB, FEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bladder

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

To support the substantial equivalence claim made herein, various bench performance studies have been performed related to:

  • Suprapubic Catheter design and performance.
  • Catheter accessory design and performance.
  • Biocompatibility
  • Sterilization Validation & Shelf Life

No clinical performance testing was performed. Substantial equivalence for the subject device is based on the aforementioned non-clinical bench studies.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K014002, K012153, K983367, K071459

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

K120127

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

1

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 DeviceManufacturer510(k)Relevance
Fortune Suprapubic
CatheterFortune Medical
Instrument Corp.K014002T-SPeCTM Suprapubic Catheter intended for bladder drainage.

510(k) Summary page 2 of 4

2

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 DeviceManufacturer510(k)Relevance
Lowsley Suprapubic
TractorCircon Corp.
(now owned by
Gyrus ACMI, Inc.)K012153T-SPECTTM Catheter Punch
Instrument:

• “inside-out” cystostomy
via transurethral bladder
access

• Capture and placement
of Suprapubic Catheter |
| Qlicksmart
BladeFLASK and
BladeSINGLE | Qlicksmart Pty.,
Ltd. | K983367 | Sharps containment feature of
the T-SPECTTM Catheter Punch
Instrument. |
| Omnifix® Syringe | B. Braun Medical
Inc. | K071459 | T-SPECTTM Piston Syringe for
inflating/deflating catheter
balloon |

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

3

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

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

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.

5

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

6

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