(119 days)
Not Found
No
The summary describes a physical medical device (catheter) with a coating and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used to drain urine in patients with chronic urine retention and voiding dysfunction, which directly alleviates a medical condition.
No
The device description indicates it is a catheter used to drain urine, not to diagnose a condition. It is a therapeutic device for managing urine retention.
No
The device description clearly states it is a physical, disposable catheter made of polyurethane, coated, and packaged in a foil bag. It is a hardware device for urine drainage.
Based on the provided information, the SpeediCath catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to drain urine from the bladder by inserting the catheter into the urethra. This is a direct intervention on the body for therapeutic purposes (draining urine), not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The device is a physical catheter designed for insertion into the body. It's coated and prelubricated to facilitate this insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like urine itself) in vitro to provide diagnostic information. The device's function is purely mechanical for drainage.
IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to detect diseases, conditions, or infections. The SpeediCath catheter does not perform such tests.
N/A
Intended Use / 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 non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
Product codes
78 GBM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, 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)
A summary of the safety testing performed on the coated catheter is listed below.
Test: Intracutaneous Test in the Rabbit, Reference: Scantox, DK Lab no.46511, Results: "Negligible" according to ISO 10993, Part 10, Section 5.4.
Test: Systemic Injection Test in the Mouse, Reference: Scantox, DK Lab no.46512, Results: No clinical signs of toxicity, meeting the requirements of USP 24 (2000).
Test: Vaginal Irritation Test - ISO Method, Reference: Sterilization Technical Services, USA Test no. T02-1551, Results: Meets the requirements of Vaginal Irritation Test ISO Method (ISO 10993-10:1995).
Test: Test for Delayed Contact Hypersensitivity Using the Guinea Pig Maximization Test, Reference: Scantox, DK Lab no. 46510, Results: No evidence of delayed contact hypersensitivity according to ISO 10993, Part 10.
Test: In Vitro Cytotoxicity Assay (Elusion test), Reference: Scantox, DK 46508, Results: Passed the requirements of USP 24 (cytotoxicity grade ≤2).
Test: Agar overlay (Cytotoxicity Assay), Reference: Nelson Laboratories, US Lab no. 215085, Results: Meets requirements of USP 25 (cytotoxicity grade ≤2).
Test: Ames test, Reference: Scantox, DK Lab no. 48826, Results: Not mutagenic (OECD guideline no. 471 (1997) and ICH Tripartite Harmonised Guidelines (1995 and 1997)).
Conclusion: Passed all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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