← Product Code [KOB](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOB) · K120127

# SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM (K120127)

_Swan Valley Medical, Incorporated · KOB · Oct 26, 2012 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOB/K120127

## Device Facts

- **Applicant:** Swan Valley Medical, Incorporated
- **Product Code:** [KOB](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOB.md)
- **Decision Date:** Oct 26, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5090
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## 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.

## Device Story

T-SPeC Surgical System is a sterile kit for suprapubic catheterization; includes suprapubic catheter, catheter punch instrument, and piston syringe. System enables 'inside-out' cystostomy via transurethral bladder access; punch instrument creates cystostomy and facilitates catheter placement; syringe used for balloon inflation/deflation. Used in clinical settings by healthcare providers. Provides bladder drainage; benefits patient by facilitating suprapubic access for urinary management.

## Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical bench performance studies.

## Technological Characteristics

Kit includes suprapubic catheter, catheter punch instrument, and piston syringe. Features 'inside-out' cystostomy mechanism via transurethral access. Biocompatible materials; sterile; shelf-life validated.

## Regulatory 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.

## Predicate Devices

- Fortune Suprapubic Catheter ([K014002](/device/K014002.md))
- Lowsley Suprapubic Tractor ([K012153](/device/K012153.md))
- Qlicksmart BladeFLASK and BladeSINGLE ([K983367](/device/K983367.md))
- Omnifix® Syringe ([K071459](/device/K071459.md))

## Submission Summary (Full Text)

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>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k121027

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator materials for sodium, potassium, chloride, carbon dioxide

D. Type of Test:
Not applicable

E. Applicant:
Diamond Diagnostics Inc.

F. Proprietary and Established Names:
Diamond Diagnostics ATAC 8000/ Envoy 500 ISE calibrators

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150; Calibrator
2. Classification:
Class II
3. Product code:
JIT
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indications for use below.
2. Indication(s) for use:
Diamond Diagnostics Calibrators for ATAC 8000 and Envoy 500 instruments are intended to provide calibration points for the Na⁺, K⁺, Cl⁻ and CO₂ electrodes on the ATAC 8000 and Envoy 500 instruments.
3. Special conditions for use statement(s):
For prescription use only

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4. Special instrument requirements:

For use with ATAC 8000 and Envoy 500 instruments

I. Device Description:

Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators consist of two calibrators, a low level and a high level. Both low and high level calibrators consist of an aqueous buffered solution of electrolytes and preservative in de-ionized water. It contains no human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution.

Each calibrator is comprised of the following concentrations of analytes:

|  ISE Calibrator | Na⁺ mmol/L | K⁺ mmol/L | Cl⁻ mmol/L | CO₂ mmol/L  |
| --- | --- | --- | --- | --- |
|  Low | 92 ± 2.0 | 3.05 ± 0.05 | 78 ± 2 | 11 ± 1  |
|  High | 162 ± 1.0 | 10.2 ± 0.1 | 126 ± 1 | 34.5 ± 1  |

J. Substantial Equivalence Information:

1. Predicate device name(s):

ATAC 8000/Envoy 500 ISE Calibrators

2. Predicate k number(s):

k945271

3. Comparison with predicate:

|   | Similarities and Differences |   |
| --- | --- | --- |
|  Item | Diamond ATAC 8000/Envoy 500 ISE Calibrators (candidate device) | ATAC 8000 ISE Calibrators (predicate device-k945271)  |
|  Intended Use | For in-vitro diagnostics use to provide calibration points for the Na⁺, K⁺, Cl⁻ and CO₂ electrodes | same  |
|  Matrix | Aqueous buffered solution of salts & preservatives in de-ionized water. Contains no human or animal materials. | same  |
|  Packaging, Vial | Glass Vial | Same  |
|  Levels | 2x20 mL | 2x6x20 mL  |
|  Storage | 18-25°C | same  |
|  Shelf Life | 24 months | same  |

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K. Standard/Guidance Document Referenced (if applicable):
None were referenced.

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

Sponsor claims traceability to the following materials and methods:

|  Analyte | Standard Used for Determination of Analyte Value | Instrument Used  |
| --- | --- | --- |
|  Na, K, | NIST 919a, 918a | IL 943 (Flame Photometry)  |
|  Cl | NIST 919a | Corning 925, SAT-500 Salt analyzer (Titrimetric)  |
|  CO2 | Clinical calibrator DD-93100 | Hitachi 912, Olympus-Beckman CX-7  |

Value Assignment:

Commercially available salts/chemical constituents are gravimetrically weighed and added to Type 1 deionized water to yield the desired concentrations. To ensure that target values are met, multiple replicates of test samples are measured at the beginning and end of the production run on multiple analyzers and must passed the target ranges prior to release. Target values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. In addition, calibrators are also tested on the ATAC 8000 and Envoy 500 instruments and must pass the target values specifications before release. The target values specifications are listed below:

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|  ISE Calibrator | Na+ mmol/L | K+ mmol/L | Cl- mmol/L | CO2 mmol/L  |
| --- | --- | --- | --- | --- |
|  Low | 92 ± 2.0 | 3.05 ± 0.05 | 78 ± 2 | 11 ± 1  |
|  High | 162 ± 1.0 | 10.2 ± 0.1 | 126 ± 1 | 34.5 ± 1  |

# Stability:

Shelf-life stability was tested using an accelerated stability study. Real-time stability study is still on-going. The accelerated stability testing protocols and acceptance criteria were described and found to be adequate. Both calibrators low and high has an estimated shelf life of 24 months when stored at  $18 - 25^{\circ}\mathrm{C}$ . There is no open-vial claim since the calibrators are designed to be used once only.

d. Detection limit: Not applicable
e. Analytical specificity: Not applicable
f. Assay cut-off: Not applicable

2. Comparison studies:

a. Method comparison with predicate device: Not applicable
b. Matrix comparison: Not applicable

3. Clinical studies:

a. Clinical Sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable

4. Clinical cut-off: Not applicable

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5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOB/K120127](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOB/K120127)

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