(185 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of the catheter, with no mention of AI or ML technologies.
Yes
The device is used for Clean Intermittent Catheterization (CIC) treatment to empty the bladder in patients with chronic urine retention, which directly addresses a health condition.
No
The device description clearly states its purpose is for "Clean Intermittent Catheterization, drainage of bladder" and "emptying the bladder," which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components such as a catheter made of PVC, hydrophilic polymer coating, a water sachet, a urine bag, and a povidone iodine swab. These are all 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 "Clean Intermittent Catheterization-CIC treatment" and "emptying the bladder" by inserting a catheter into the urethra. This is a direct intervention on the body for drainage, not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The device is a physical catheter designed for insertion and drainage. While it uses a hydrophilic coating activated by water, this is a functional aspect of the device itself, not a component for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine, blood, etc.) to provide diagnostic information. The device's function is purely mechanical for drainage.
- Performance Studies: The performance studies focus on safety testing related to biocompatibility and toxicity, which are typical for medical devices that come into contact with the body, not for IVDs which focus on analytical performance.
In summary, the Hi-Slip, Hi-Slip Plus, and Hi-Slip Kit are medical devices used for a therapeutic procedure (bladder drainage), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
Product codes (comma separated list FDA assigned to the subject device)
GBM/Catheter,Urethral, EZD
Device Description
The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths.
The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths.
Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.
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.
Table: 3.7 Summary of Safety Tests
Investigaton of Acute Systemic Toxicity Test: Bioserv Analytik Und Medizinprodukte, Did not cause any acute toxicity, meeting the requirements of ISO 10933-11
Closed Patch Sensitization Test: Did not cause any sensitization, meeting the requirements of DIN ISO 10933-10
Salmonella typhimurium Reverse Mutation Assay: Did not cause any genotoxic activity, meeting the requirements of DIN ISO 10933-3
Cytotoxicity Assay: Caused no toxicological/biological critical cell damages and growth inhibition. Under these conditions the test material is considered non-cytotoxic and meets the requirements of DIN ISO 10993-5 (EN 30993-5)
Skin Irritation Test: Did not cause any irritation under the selected test conditions P.I.O.:0,0., meeting the requirements of DIN ISO 10993-10
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.
K896750, K012374, K023254, K000070, K050874, K043241, K973070
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
§ 876.5130 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.
0
pg 1 of 9
510(k) SUMMARY
FEB 2 2 2007
3.1. Submitter
Contact Person: Phone number:
Fax number:
Oasis Medikal Ürünler Kimya Sanayi ve Tic.A.S. Yıdızevler Mah. 4. Cad. 82. Sok. Cankaya 06550, ANKARA TURKEY Ayşe Yerlikaya +90312 4388353 +90312 4411220
Date of Preparation of the Summary: August 16th, 2006
3.2. Device Name
A-Device Name-CATHETER
Classification Name: Urological Catheter Urinary Catheter for Intermittent Use Common/Usual Name: Proprietary Name: Hi-Slip
B-Device Name-CATHETER
| Classification Name: | Urological Catheter |
|---|---|
| Common/Usual Name: | Urinary Catheter for Intermittent Use |
| Proprietary Name: | Hi-Slip Plus |
C-Device Name-CATHETER
Classification Name: Common/Usual Name: Proprietary Name:
Urological Catheter Kit Urinary Catheter Kit for Intermittent Use Hi-Slip Kit
3.3. Device Classification
Hi-Slip, Hi-Slip Plus and Hi-Slip Kit all have been classified by the FDA under the heading of Urological Catheters and Accessories as a Class II device in accordance with the regulations under 21 CFR 876.5130. Thev are all Prescription Devices meaning they can be sold by or on the offer of a physician.
The appropriate panel is Gastroenterology or Urology and the Product Code is GBM/Catheter,Urethral.
1
K 062444
J72gg
3.4. Device Description
The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths.
The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths.
Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.
3.5. Intended Use
Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are all launched for Clean Intermittent Catheterization-CIC treatment and indicated for use by patients with chronic urine refention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
3.6. Summary of Technological Characteristics/Statement of Substantial Equivalence:
All predicate catheters are single use and intended for single intermittent catheterization.
2
Image /page/2/Picture/0 description: The image contains handwritten text. The top line reads "Kob24444". The second line reads "Pg 3 of 9". The text appears to be written in black ink on a white background.
The catheter is pre-lubricated with a coating containing polyvinyl pyrrolidone- a kind of hydrophilic polymer (PVP), which binds the water molecules to the surface of the catheter to reduce the risk of friction while inserting the catheter into the urethra.
Hi-Slip is substantially equivalent to the following predicate devices:
- · LoFric®Single Use Urinary Catheter K896750, Astra Tech Inc.
- LoFric®Plus Single Use Urinary Catheter K012374, Astra Tech Inc. .
- SpeediCath K023254, Coloplast Corp. .
- FloaCath Catheter K000070, Rüsch International. .
Hi-Slip Plus (with water sachet) is substantially equivalent to the following predicate devices:
- · LoFric® Primo Single Use Urinary Catheter K050874, Astra Tech Inc.
- SpeediCath K023254, Coloplast Corp. .
Hi-Slip Kit (with urine bag, water sachet and povidone iodine swab) is substantially equivalent to the following predicate devices:
- · LoFric®Plus Hydro-Kit II Single Use Urinary Catheter K043241, Astra Tech Inc.
- EasiCath Set K973070, Coloplast Corp. Branded as the SureCath Set . in the US.
3
K062444
Ry489
3.7. Substantial Equivalence Comparison:
Boys/Pediatric
30 cm, CH06-10
Girls/Pediatric
20 cm, CH06-10
Tiemann 40 cm,
CH10-18
| Table 3.1.
| Properties | Hi-Slip-Substantial Equivalence Comparison - General | |||
|---|---|---|---|---|
| Hi-Slip | ||||
| Hydrophilic | ||||
| Urinary | ||||
| Catheter | LoFric® Single | |||
| Use Urinary | ||||
| Catheter, Astra | ||||
| Tech Inc. | LoFric® Plus | |||
| Single Use | ||||
| Urinary Catheter, | ||||
| Astra Tech Inc. | SpeediCath | |||
| Coloplast | ||||
| Corp. | ||||
| 510 (k) | ||||
| number | K896750 | K012374 | K023254 | |
| Device | ||||
| composition | Polyvinyl | |||
| chloride (PVC) | ||||
| catheter | ||||
| coated | ||||
| with | ||||
| polyvinylpyr- | ||||
| rolidone. | Polyvinylchloride | |||
| (PVC) catheter | ||||
| coated with | ||||
| polyvinylpyr- | ||||
| rolidone and | ||||
| salt. | Polyether block | |||
| amide catheter | ||||
| coated with | ||||
| polyvinyl- | ||||
| pyrrolidone and | ||||
| salt. | Polyurethane | |||
| catheter | ||||
| coated | ||||
| with | ||||
| polyvinylpyr- | ||||
| rolidone, | ||||
| placed in | ||||
| a saline | ||||
| solution | ||||
| containing | ||||
| polivinyl- | ||||
| pyrrolidone. | ||||
| Sizes | Male 40 cm, | |||
| CH08-24 |
Female 20 cm,
CH08-18 | Male 40 cm
CH 08-24
Female 15 cm
CH 08-14
Female 20 cm | Male 40 cm
CH 08-24
Female 20 cm
CH 08-18 | Male 40 cm
CH08-18
Female 20 cm
CH 06-16 |
CH 08-18
Pediatric 20 cm
CH06-10
Pediatric 30 cm
CH06-10
Tiemann 40 cm CH 10-18
Pediatric 20 cm
CHOP-10
Pediatric 30 cm
CHO6-10
Tiemann 40 cm
CH 10-18
Pediatric 20
cm
CH 06-10
Tiemann 40
cm
CH 10-14
4
K062444
pg 5089
| | Hi-Slip
Hydrophilic
Urinary Catheter | LoFric® Single
Use Urinary
Catheter, Astra
Tech Inc. | LoFric® Plus
Single Use Uri-
nary Catheter,
Astra Tech Inc. | SpeediCath
Coloplast
Corp. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Function of
the
device | Inserted into the
bladder through
the urethra for
emptying the
bladder | Inserted into the
bladder through
the urethra for
emptying the
bladder | Inserted into
the bladder
through the
urethra for
emptying the
bladder | Inserted into
the bladder
through the
urethra for
emptying the
bladder |
| Indication
for use | Intermittent
catheterization
(Because of
chronic urine
retention and
other voiding
dysfunctions. | Intermittent
catheterization | Intermittent
catheterization | Chronic urine
re-
tention,
post-void
residual
volume (PVR)
and voiding
dysfunctions. |
| Features
of the
device | Hydrophilic
coated. Slippery
surface. Low
friction between
catheter and
urethral mucosa. | Hydrophilic
coated. Low
friction between
catheter
and urethral
mucosa. | Hydrophilic
coated. Low
friction
between
catheter
and urethral
mucosa. | Hydrophilic
coated.
Low friction
between
catheter and
urethral
mucosa.
Ready to use. |
| Sterility | Sterile | Sterile | Sterile | Sterile |
| Packaging | Peel Pack | Peel Pack | Peel Pack | Peel Pack |
| Table 3.2. Hi-Slip-Substantial Equivalence Comparison: Indications for Use | ||
|---|---|---|
| -- | -- | ---------------------------------------------------------------------------- |
. 11
5
Kob2444
Pg6qgg
| Properties | Hi-Slip Plus
Hydrophilic Urinary
Catheter | LoFric® Primo Single
Use Urinary
Catheter, Astra
Tech Inc. | SpeediCath
Coloplast
Corp. |
|-----------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k)
number | | K050874 | K023254 |
| Device
composition | Polyvinyl chloride
(PVC)
catheter coated
with polyvinylpyr
rolidone and sterile
water sachet | Polyvinylchloride
(PVC) catheter
coated with
polyvinylpyr-
rolidone and salt and
water sachet | Polyurethane
catheter coated
with polyvinylpyr-
rolidone, placed in
a saline solution
containing
polivinyl-
pyrrolidone. |
| Sizes | Male 40 cm,
CH08-24
Female 20 cm,
CH08-18 | Male 40 cm
CH 10-18
Female 20 cm
CH 08-18 | Male 40 cm
CH08-18
Female 20 cm
CH 06-16 |
| | Boys/Pediatric
30 cm, CH06-10
Girls/Pediatric
20 cm, CH06-10 | Pediatric 20 cm
CH08-10 | Pediatric 20 cm
CH 06-10
Tiemann 40 cm
CH 10-14 |
| Table 3.3. Hi-Slip Plus-Substantial Equivalence Comparison: General | ||||
|---|---|---|---|---|
| Properties |
:
6
K062444
pg 7 of 9
| Use | Hi-Slip Plus Hydrophilic
Urinary Catheter | LoFric® Primo Single
Use Urinary
Catheter, Astra
Tech Inc. | SpeediCath
Coloplast
Corp. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Function of
the
device | Inserted into the
bladder through the
urethra for emptying
the bladder | Inserted into the
bladder through the
urethra for emptying
the bladder | Inserted into the
bladder through
the urethra for
emptying the
bladder |
| Indication for
use | Intermittent
catheterization
(Because of chronic
urine retention and
other voiding
dysfunctions. | Intermittent
catheterization | Chronic urine re-
tention,
post-void residual
volume (PVR)
and voiding
dysfunctions. |
| Features
of the
device | Hydrophilic coated.
Slippery surface. Low
friction between
catheter and
urethral mucosa.
Ready to use. | Hydrophilic coated.
Low friction between
catheter
and urethral mucosa.
Ready to use. | Hydrophilic
coated.
Low friction
between catheter
and urethral
mucosa. Ready to
use. |
| Sterility | Sterile | Sterile | Sterile |
| Packaging | Peel Pack | Closed PVC | Peel Pack |
Table 3.4. Hi-Slip Plus-Substantial Equivalence Comparison: Indications for lise
:
7
Pg 8 of 9
| Properties: | Hi-Slip Kit-Substantial Equivalence Comparison: | General | |
|---|---|---|---|
| Hi-Slip Hydrophilic | |||
| Urinary Catheter Kit | LoFric® Plus | ||
| Hydro-Kit II Single | |||
| Use Urinary | |||
| Catheter Astratech | |||
| Inc. | EasiCath Set | ||
| (identical to | |||
| the SureCath | |||
| Set) Coloplast | |||
| Corp. | |||
| 510 (k) | |||
| number | K043241 | K973070 | |
| Device | |||
| composition | PVC catheter coated | ||
| with PVP. Then sterile | |||
| water sachet povidone | |||
| iodine swab and the | |||
| catheter are placed | |||
| into the urine bag and | |||
| the bag is sealed. | Polyvinylchloride | ||
| catheter coated | |||
| with polyvinylpyr | |||
| rolidone and salt. | |||
| Includes water | |||
| sachet and urine | |||
| bag. | Polyvinylchloride | ||
| catheter coated with | |||
| polyvinylpyrrolidone, | |||
| packed | |||
| with an ampoule with | |||
| sterile saline solution and | |||
| sealed in a urine | |||
| collection bag. | |||
| Sizes | Male 08-18 CH | ||
| Female 08-16 CH | |||
| Pediatric Girls 06-10 CH | |||
| Pediatric Boys 06-10 | |||
| CH | |||
| Tiemann 10-18 CH | Male CH 08-18 | ||
| Female CH 08-18 | |||
| Pediatric CH 06-10 | |||
| Tiemann CH 10-18 | Male CH 08-18 | ||
| Female CH 08-14 | |||
| Pediatric CH 06-10 |
. . . .
Table 3.6. Hi-Slip Kit-Substantial Equivalence Comparison: Indications for Use
| | Hi-Slip Hydrophilic
Urinary Catheter Kit | Lofric Plus
Hydro-Kit II Single
Use Urinary Catheter
Astratech Inc. | EasiCath Set
(identical to
the SureCath
Set) ColoplastCorp |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Function of
the device | Inserted into the
urethra till catheter
reaches bladder and
allows urine to drain
into urine collection
bag. | Inserted into the
urethra till catheter
reaches bladder and
allows urine to drain
into urine collection
bag. | Inserted into the urethra
till catheter reaches
bladder and allows urine
to drain into urine
collection bag. |
| Indication
for use | Intermittent
catheterization
because of chronic
urine retention and
other voiding
dysfunctions. | Chronic urine
retention and
voiding dysfunctions. | Chronic urine retention
and voiding
dysfunctions. |
| Features
of the
device | Hydrophilic coated.
Slippery surface. Low
friction between
catheter and
urethral mucosa.
Ready to use. | Hydrophilic coated.
Low friction between
catheter and
urethral mucosa.
Ready to use. | Hydrophilic coated. Low
friction between
catheter and urethral
mucosa. Ready to use. |
8
Jy 9 of 9
| · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
Sterily | and second address of there a a supportunes of
Sterle | a sual challed and different were any are any and
when and fully for the province of
Sterle | A FOR A MONE AND ENGINEER AND AND
Sterile |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packagina | A | of the property of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first | 200000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 |
| | Papl | Peel Pack | 000 |
| | ปากม | assessfully and the research as a may as any assessment | a si i i i i i i a |
| | LA MA LE MINNER FOR LEASE LE / CONSULE CONSULTION CARREED IN AND AND AND AND IN AND WINNER OF | results and relation of the laboration and compress of the compress of the compress of the compress of the compress of the compress of the compress of the compressional progr | control can be and the program and the line of the line of the line of the line in the line in the line in the line in the line in the line in the line in the line in the lin |
3.8. Summary of Safety Testing
. . .
A summary of the safety testing performed on the coated catheter is listed below.
Table: 3.7 Summary of Safety Tests
| Test | Reference | Results |
|---|---|---|
| Investigaton of | ||
| Acute Systemic | ||
| Toxicity Test | Bioserv Analytik | |
| Und | ||
| Medizinprodukte | Did not cause any acute toxicity, | |
| meeting the requirements of ISO | ||
| 10933-11 | ||
| Closed Patch | ||
| Sensitization Test | Did not cause any sensitization, | |
| meeting the requirements of DIN | ||
| ISO 10933-10 | ||
| Salmonella | ||
| typhimurium | ||
| Reverse | ||
| Mutation Assay | Did not cause any genotoxic | |
| activity, meeting the requirements | ||
| of DIN ISO 10933-3 | ||
| Cytotoxicity | ||
| Assay | Caused no | |
| toxicological/biological critical | ||
| cell damages and growth | ||
| inhibition. Under these conditions | ||
| the test material is considered | ||
| non-cytotoxic and meets the | ||
| requirements of DIN ISO 10993-5 | ||
| (EN 30993-5) | ||
| Skin Irritation | ||
| Test | Did not cause any irritation under | |
| the selected test conditions | ||
| P.I.O.:0,0., meeting the | ||
| requirements of DIN ISO 10993-10 |
Conclusion: 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/16 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The eagle is composed of thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OASIS Medikal Ürünler c/o Mr. Charles H. Kyper Kyper & Associates 208 Barrington Overlook DURHAM NC 27703
FEB 2 2 2007
Re: K062444
Trade/Device Name: Hi-Slip Single Use Hydrophilic Urinary Catheter Hi-Slip Plus Single Use Hydrophilic Urinary Catheter with water sachet Hi-Slip Single Use Hydrophilic Urinary Catheter Kit with water sachet, urine bag and povidone iodine swab
Regulation Number: 21 CFR §876.5130
Regulation Name: Urological catheter and accessories Regulatory Class: II
Product Code: EZD Dated: January 24, 2007
Received: January 26, 2007
Dear Mr. Kyper:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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
10
Page 2 - Mr. Charles Kyper
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.
In addition, we have determined that your device kit contains a povidone iodine swab which is subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'' (21 CFR Part 807.97). 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David A. Segerson
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
INDICATIONS FOR USE
510(k) Number (if known): K062444
Device Name:
Hi-Slip Single Use Hydrophilic Urinary Catheter
Hi-Slip Plus Single Use Hydrophilic Urinary Catheter with water sachet
Hi-Slip Single Use Hydrophilic Urinary Catheter Kit with water sachet, urine bag and povidone iodine swab
Indications for Use:
Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use -(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number.
Section-2, Indication for Use Statement, Page 1/1