The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Device Description

The SpeediCath Catheter is a single use, disposable polyurethane catheter. It is coated and placed in a saline solution, packed and sealed in a foil bag and sterilized. The catheter is prelubricated with a coating containing polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance for SpeediCath

The SpeediCath 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, and safety testing rather than a specific clinical performance study with predefined acceptance criteria. The acceptance criteria for the device are therefore implicit in meeting the requirements for general safety and effectiveness and showing equivalence to legally marketed devices.

The "studies" conducted are primarily non-clinical safety tests to ensure biocompatibility and absence of toxicity.

Here's a table summarizing the "acceptance criteria" (implied by the test objective) and the reported device performance for the safety testing:

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Intracutaneous Test in the Rabbit	Negligible irritation according to ISO 10993, Part 10, Section 5.4.	"Negligible" according to ISO 10993, Part 10, Section 5.4.
Systemic Injection Test in the Mouse	No clinical signs of toxicity, meeting the requirements of USP 24 (2000).	No clinical signs of toxicity, meeting the requirements of USP 24 (2000).
Vaginal Irritation Test - ISO Method	Meets the requirements of Vaginal Irritation Test ISO Method (ISO 10993-10:1995).	Meets the requirements of Vaginal Irritation Test ISO Method (ISO 10993-10:1995).
Test for Delayed Contact Hypersensitivity Using the Guinea Pig Maximization Test	No evidence of delayed contact hypersensitivity according to ISO 10993, Part 10.	No evidence of delayed contact hypersensitivity according to ISO 10993, Part 10.
In Vitro Cytotoxicity Assay (Elution test)	Cytotoxicity grade ≤2, meeting USP 24 requirements.	Passed the requirements of USP 24 (cytotoxicity grade ≤2).
Agar overlay (Cytotoxicity Assay)	Cytotoxicity grade ≤2, meeting USP 25 requirements.	Meets requirements of USP 25 (cytotoxicity grade ≤2).
Ames test	Not mutagenic according to OECD guideline no. 471 (1997) and ICH Tripartite Harmonised Guidelines (1995 and 1997).	Not mutagenic (OECD guideline no. 471 (1997) and ICH Tripartite Harmonised Guidelines (1995 and 1997)).

Conclusion: All tests were passed, indicating the device meets the safety criteria established for these specific biological compatibility assessments.

2. Sample Size for Test Set and Data Provenance

The provided document describes safety testing rather than a diagnostic performance study that would typically involve a "test set" of patient data.

Sample Size for Test Set: Not applicable in the context of the provided safety testing. The "samples" were biological subjects (rabbits, mice, guinea pigs) or in-vitro cell cultures used for biocompatibility assessments, not a test set of patient data. Specific numbers for animals used are not detailed but are implied by the standard test methods (e.g., "the Rabbit," "the Mouse," "the Guinea Pig").
Data Provenance: The tests were conducted by independent laboratories:
- Scantox, DK (Denmark) for most tests.
- Sterilization Technical Services, USA for the Vaginal Irritation Test.
- Nelson Laboratories, US for the Agar overlay (Cytotoxicity Assay).
- These were prospective tests conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The studies are biological safety tests, not diagnostic studies requiring expert review of results to establish ground truth for a medical condition.
Qualifications of Experts: N/A. The interpretation of these biological safety tests is performed by qualified laboratory personnel following established international and national standards (ISO, USP, OECD).

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among multiple experts in diagnostic studies. For these safety tests, results are objectively measured and interpreted against predefined criteria in the respective standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The document does not describe an MRMC comparative effectiveness study. This type of study is used for diagnostic algorithms to assess the impact of AI assistance on human reader performance. The SpeediCath is an intermittent urinary catheter, a medical device for direct physiological intervention (draining urine), not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: No. This concept is for AI algorithms and is not applicable to an intermittent urinary catheter. The "performance" of the catheter is related to its physical and biological properties to facilitate urine drainage safely and effectively, which is assessed through bench testing, biocompatibility studies, and comparison to predicate devices, not an algorithm's standalone accuracy.

7. Type of Ground Truth Used

Type of Ground Truth: For the safety studies, the "ground truth" is established by the objective outcomes of the standardized biological and chemical tests themselves, as per the specified international (ISO, OECD) and national (USP) guidelines. For example, "no clinical signs of toxicity" during a systemic injection test, or "not mutagenic" in an Ames test. This is not clinical ground truth like pathology or outcomes data in humans, but rather biological safety endpoints.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The SpeediCath is a physical medical device, not an AI algorithm that requires a training set of data.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

Summary

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K023254
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SpeediCath 510(k) SUMMARY Page 1 of 4

Coloplast Corp 1. Submitter: 1940 Commerce Drive Mankato, MN 56003 USA
Elizabeth Boots Contact Person:

507-386-4362 Phone number:

Fax number: 507-345-3291

September 19, 2002 Date of Preparation:

2. Device name:

Classification Name: Urological Catheter Common/usual name: Urinary Catheter for intermittent use Proprietary Name: Speedicath

Device Classification: 3.

The SpeediCath Catheter has been classified by the FDA under the heading of Urological Catheters and accessories as a Class II device.

4. Statement of Substantial Equivalence:

SpeediCath is substantially equivalent to the following predicate devices:

EasiCath Set K973070, Coloplast Corp. Branded as the SureCath Set . in the US.
LoFric®Single Use Urinary Catheter K896750, Astra Tech Inc. .
LoFric®Plus Single Use Urinary Catheter K012374. Astra Tech Inc. .

5. Intended Use:

Device Description: 6.

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K023254
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SpeediCath 510(k) SUMMARY Page 2 of 4

Substantial equivalence comparison

A comparison matrix for the SpeediCath versus the predicate devices is presented below:

	SpeediCath	EasiCath Set(identical tothe SureCathSet) ColoplastCorp	LoFric®SingleUse UrinaryCatheter, AstraTech Inc.	LoFric®PlusSingle Use Uri-nary Catheter,Astra Tech Inc.
510 (k)num-ber		K973070	K896750	K012374
Devicecom-posi-tion	Polyurethanecatheter coatedwith polyvinylpyr-rolidone, placed ina saline solutioncontaining polyvi-nylpyrrolidone.	Polyvinylchloridecatheter coatedwith polyvinylpyr-rolidone, packedwith an ampoulewith sterile salinesolution andsealed in a urinecollection bag.	Polyvinylchloridecatheter coatedwith polyvinylpyrrolidone and salt.	Polyether blockamide cathetercoated with poly-vinylpyrrolidoneand salt.
Sizes	Female Ch. 6, 8,10, 12, 14, 16Male Ch. 8, 10, 12,14, 16, 18Tiemann Ch. 10,12, 14Pediatric Ch. 6,8,10Boy Ch. 6, 8, 10,12	Female Ch. 8,10, 12, 14Male Ch. 8, 10,12, 14, 16, 18Pediatric Ch. 6,8, 10	Female 150mmCh. 8, 10, 12, 14Female 200mmCh. 8, 10, 12, 14,16, 18Male Ch. 8, 10,12, 14, 16, 18, 20,22, 24Tiemann Ch. 10,12, 14, 16, 18Pediatric 200mmCh. 6, 8, 10Boy Ch. 6, 8, 10(Sizes currentlyon the market inthe US)	Information notavailable

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K023254
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	SpeediCath	EasiCath Set(identical to theSureCath Set)Coloplast Corp	LoFric®SingleUse UrinaryCatheter, AstraTech Inc.	LoFric®PlusSingle UseUrinary Cathe-ter, Astra TechInc.
Func-tion ofthedevice	Inserted into theurethra till catheterreaches bladderand allows urine todrain.	Inserted into theurethra till catheterreaches bladderand allows urine todrain into urine col-lection bag.	Inserted into theurethra tillcatheterreaches bladderand allows urineto drain.	Inserted into theurethra till cathe-ter reaches blad-der and allowsurine to drain.
Indica-tion foruse	Chronic urine re-tention.Post-void residualvolume (PVR).Voiding dysfunc-tions.	Chronic urine re-tention.Voiding dysfunc-tions.	Intended use issubstantiallyequivalent toLoFric® PlusSingle Use Uri-nary Catheter(according toK012374 Sum-mary).	Intermittent cath-erization of theurethra.
Fea-turesof thedevice	Hydrophilic coated.Low friction be-tween catheter andurethral mucosa.Ready to use.	Hydrophilic coated.Low friction be-tween catheter andurethral mucosa.	Hydrophiliccoated.Low friction be-tween catheterand urethralmucosa.	Hydrophiliccoated.Low friction be-tween the cathe-ter and urethralmucosa.
Steril-ity	Sterile	Sterile	Sterile	Sterile
Pack-aging	Peel Pack	Peel Pack	Peel Pack	Peel Pack

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K023254
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SpeediCath 510(K) SUMMARY Page 4 of 4

7. Summary of Safety Testing:

A summary of the safety testing performed on the coated catheter is listed below.

Test	Reference	Results
Intracutaneous Test in theRabbit	Scantox, DKLab no.46511	"Negligible" accordingto ISO 10993, Part 10,Section 5.4.
Systemic Injection Test inthe Mouse	Scantox, DKLab no.46512	No clinical signs of tox-icity, meeting the re-quirements of USP 24(2000).
Vaginal Irritation Test -ISO Method	Sterilization TechnicalServices, USATest no. T02-1551	Meets the requirementsof Vaginal Irritation TestISO Method (ISO10993-10:1995).
Test for Delayed ContactHypersensitivity Using theGuinea Pig MaximizationTest	Scantox, DKLab no. 46510	No evidence of delayedcontact hypersensitivityaccording to ISO10993, Part 10.
In Vitro Cytotoxicity Assay(Elusion test)	Scantox, DK46508	Passed the require-ments of USP 24 (cyto-toxicity grade ≤2).
Agar overlay (CytotoxicityAssay)	Nelson Laboratories, USLab no. 215085	Meets requirements ofUSP 25 (cytotoxicitygrade ≤2)
Ames test	Scantox, DKLab no. 48826	Not mutagenic (OECDguideline no. 471(1997) and ICH TripartiteHarmonised Guide-lines (1995 and 1997))

Conclusion: Passed all tests.

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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 2003

Ms. Elizabeth Boots Vice President Quality Assurance Coloplast Corp. 1940 Commerce Drive NORTH MANKATO, MN 56003 Re: K023254

Trade/Device Name: SpeediCath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 GBM Dated: January 15, 2003 Received: January 16, 2003

Dear Ms. Boots:

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.

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); 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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Page 2

This letter will allow you to begin marketing your device as described in your 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21 CFR 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 yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023254
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510(k) Number (if known): ≤ △ 乙乙乙乙乙 ×

Device Name: SpeediCath

Indications for Use:

The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

(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)

Over-The-Counter Use_

(Optional Format 1-2-96)

David A. Ingram

Onrision Sinn-510k) Nu

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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.