Who is the manufacturer of SPEEDICATH?

Coloplast Corp. filed the 510(k) submission for SPEEDICATH (K023254).

What is the FDA product code for SPEEDICATH?

GBM. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SPEEDICATH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPEEDICATH?

EasiCath Set (K973070); LoFric Single Use Urinary Catheter (K896750); LoFric Plus Single Use Urinary Catheter (K012374).

Who can help prepare an FDA 510(k) submission like SPEEDICATH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPEEDICATH

K023254 · Coloplast Corp. · GBM · Jan 27, 2003 · Gastroenterology, Urology

Device Facts

Record ID	K023254
Device Name	SPEEDICATH
Applicant	Coloplast Corp.
Product Code	GBM · Gastroenterology, Urology
Decision Date	Jan 27, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic

Intended 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 non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Device Story

SpeediCath is a single-use, disposable, hydrophilic-coated polyurethane urinary catheter. Device is pre-lubricated with a polyvinylpyrrolidone coating that binds water to the surface, creating a smooth, low-friction film for insertion. Catheter is stored in a saline solution within a sealed foil bag. Used for intermittent catheterization to drain the bladder in patients with voiding dysfunction. Operated by patients or clinicians. Output is the mechanical drainage of urine from the bladder. Benefits include reduced friction against urethral mucosa during insertion, facilitating easier catheterization for patients with chronic retention or PVR.

Clinical Evidence

Bench testing only. Safety testing included intracutaneous rabbit test, systemic mouse injection, vaginal irritation (ISO 10993-10), guinea pig maximization test for hypersensitivity, in vitro cytotoxicity (USP 24/25), agar overlay, and Ames test for mutagenicity. All tests passed.

Technological Characteristics

Polyurethane catheter with polyvinylpyrrolidone hydrophilic coating; saline solution storage; peel-pack packaging; sterile. Dimensions vary by French (Ch) size (6-24) and tip type (standard/Tiemann). No electronic components or software.

Indications for Use

Indicated for patients with chronic urine retention and post-void residual volume (PVR) due to neurogenic or non-neurogenic voiding dysfunction requiring intermittent urethral catheterization.

Regulatory Classification

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).

Predicate Devices

EasiCath Set (K973070)
LoFric Single Use Urinary Catheter (K896750)
LoFric Plus Single Use Urinary Catheter (K012374)

Related Devices

K180258 — SpeediCath Standard · Coloplast · Oct 25, 2018
K200142 — SpeediCath Soft · Coloplast · Jul 30, 2020
K050874 — ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER · Astra Tech, Inc. · May 5, 2005
K150935 — SpeediCath Compact Eve · Coloplast A/S · Jul 2, 2015
K072808 — SPEEDICATH COMPACT · Coloplast Corp. · Nov 9, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ K023254 Page 1 of 4 # 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: 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: 6. 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. {1}------------------------------------------------ 20 K023254 Page 2 of 4 # 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 to the SureCath Set) Coloplast Corp | LoFric®Single Use Urinary Catheter, Astra Tech Inc. | LoFric®Plus Single Use Uri- nary Catheter, Astra Tech Inc. | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | 510 (k) num- ber | | K973070 | K896750 | K012374 | | Device com- posi- tion | Polyurethane catheter coated with polyvinylpyr- rolidone, placed in a saline solution containing polyvi- nylpyrrolidone. | Polyvinylchloride catheter coated with polyvinylpyr- rolidone, packed with an ampoule with sterile saline solution and sealed in a urine collection bag. | Polyvinylchloride catheter coated with polyvinylpyrrolidone and salt. | Polyether block amide catheter coated with poly- vinylpyrrolidone and salt. | | Sizes | Female Ch. 6, 8, 10, 12, 14, 16 Male Ch. 8, 10, 12, 14, 16, 18 Tiemann Ch. 10, 12, 14 Pediatric Ch. 6, 8,10 Boy Ch. 6, 8, 10, 12 | Female Ch. 8, 10, 12, 14 Male Ch. 8, 10, 12, 14, 16, 18 Pediatric Ch. 6, 8, 10 | Female 150mm Ch. 8, 10, 12, 14 Female 200mm Ch. 8, 10, 12, 14, 16, 18 Male Ch. 8, 10, 12, 14, 16, 18, 20, 22, 24 Tiemann Ch. 10, 12, 14, 16, 18 Pediatric 200mm Ch. 6, 8, 10 Boy Ch. 6, 8, 10 (Sizes currently on the market in the US) | Information not available | {2}------------------------------------------------ K023254 page 3 of 4 # | | SpeediCath | EasiCath Set (identical to the SureCath Set) Coloplast Corp | LoFric®Single Use Urinary Catheter, Astra Tech Inc. | LoFric®Plus Single Use Urinary Cathe- ter, Astra Tech Inc. | |-----------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Func- tion of the device | Inserted into the urethra till catheter reaches bladder and allows urine to drain. | Inserted into the urethra till catheter reaches bladder and allows urine to drain into urine col- lection bag. | Inserted into the urethra till catheter reaches bladder and allows urine to drain. | Inserted into the urethra till cathe- ter reaches blad- der and allows urine to drain. | | Indica- tion for use | Chronic urine re- tention. Post-void residual volume (PVR). Voiding dysfunc- tions. | Chronic urine re- tention. Voiding dysfunc- tions. | Intended use is substantially equivalent to LoFric® Plus Single Use Uri- nary Catheter (according to K012374 Sum- mary). | Intermittent cath- erization of the urethra. | | Fea- tures of the device | Hydrophilic coated. Low friction be- tween catheter and urethral mucosa. Ready to use. | Hydrophilic coated. Low friction be- tween catheter and urethral mucosa. | Hydrophilic coated. Low friction be- tween catheter and urethral mucosa. | Hydrophilic coated. Low friction be- tween the cathe- ter and urethral mucosa. | | Steril- ity | Sterile | Sterile | Sterile | Sterile | | Pack- aging | Peel Pack | Peel Pack | Peel Pack | Peel Pack | {3}------------------------------------------------ K023254 Page 4 of 4 22 # 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 the Rabbit | Scantox, DK Lab no.46511 | "Negligible" according to ISO 10993, Part 10, Section 5.4. | | Systemic Injection Test in the Mouse | Scantox, DK Lab no.46512 | No clinical signs of tox- icity, meeting the re- quirements of USP 24 (2000). | | Vaginal Irritation Test - ISO Method | Sterilization Technical Services, USA Test no. T02-1551 | Meets the requirements of Vaginal Irritation Test ISO Method (ISO 10993-10:1995). | | Test for Delayed Contact Hypersensitivity Using the Guinea Pig Maximization Test | Scantox, DK Lab no. 46510 | No evidence of delayed contact hypersensitivity according to ISO 10993, Part 10. | | In Vitro Cytotoxicity Assay (Elusion test) | Scantox, DK 46508 | Passed the require- ments of USP 24 (cyto- toxicity grade ≤2). | | Agar overlay (Cytotoxicity Assay) | Nelson Laboratories, US Lab no. 215085 | Meets requirements of USP 25 (cytotoxicity grade ≤2) | | Ames test | Scantox, DK Lab no. 48826 | Not mutagenic (OECD guideline no. 471 (1997) and ICH Tripartite Harmonised Guide- lines (1995 and 1997)) | Conclusion: Passed all tests. {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" 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ K023254 Page 1 of 1 510(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 OR Onrision Sinn-510k) Nu

SPEEDICATH

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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SPEEDICATH

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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