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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for Hi-Slip, Hi-Slip Plus, and Hi-Slip Kit urinary catheters, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to already marketed devices based on technological characteristics and intended use.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the provided text, noting its limitations:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or a table of reported device performance in the context of comparative effectiveness or specific performance metrics for the Hi-Slip products. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of device composition, sizes, function, indications for use, features, sterility, and packaging. The "Summary of Safety Testing" section (Table 3.7) provides results for biocompatibility tests, but these are pass/fail criteria against ISO standards, not performance metrics.

Test	Acceptance Criteria (Reference Standard)	Reported Device Performance
Investigation of Acute Systemic Toxicity	ISO 10933-11	"Did not cause any acute toxicity" (Passed)
Closed Patch Sensitization Test	DIN ISO 10933-10	"Did not cause any sensitization" (Passed)
Salmonella typhimurium Reverse Mutation Assay	DIN ISO 10933-3	"Did not cause any genotoxic activity" (Passed)
Cytotoxicity Assay	DIN ISO 10993-5 (EN 30993-5)	"Caused no toxicological/biological critical cell damages and growth inhibition." (Non-cytotoxic)
Skin Irritation Test	DIN ISO 10993-10	"Did not cause any irritation under the selected test conditions" (Passed)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention any specific "test set" in the context of a clinical performance study. The safety tests listed in Table 3.7 would have involved samples of the device material, but the sample sizes (e.g., number of animals or cell cultures) are not specified. Data provenance (country of origin, retrospective/prospective) is not provided for these safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The safety tests typically rely on standardized laboratory protocols and measurements, not expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical catheter, not an AI diagnostic tool involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the safety tests (biocompatibility), the "ground truth" or reference is adherence to the specified ISO/DIN standards and observed biological responses (e.g., absence of toxicity, sensitization, genotoxicity, irritation, or critical cell damage).

8. The sample size for the training set

Not applicable. This device is a physical medical catheter, not an AI or algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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K062444

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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.

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3.4. Device Description

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.

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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.

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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-SlipHydrophilicUrinaryCatheter	LoFric® SingleUse UrinaryCatheter, AstraTech Inc.	LoFric® PlusSingle UseUrinary Catheter,Astra Tech Inc.	SpeediCathColoplastCorp.
510 (k)number		K896750	K012374	K023254
Devicecomposition	Polyvinylchloride (PVC)cathetercoatedwithpolyvinylpyr-rolidone.	Polyvinylchloride(PVC) cathetercoated withpolyvinylpyr-rolidone andsalt.	Polyether blockamide cathetercoated withpolyvinyl-pyrrolidone andsalt.	Polyurethanecathetercoatedwithpolyvinylpyr-rolidone,placed ina salinesolutioncontainingpolivinyl-pyrrolidone.
Sizes	Male 40 cm,CH08-24Female 20 cm,CH08-18	Male 40 cmCH 08-24Female 15 cmCH 08-14Female 20 cm	Male 40 cmCH 08-24Female 20 cmCH 08-18	Male 40 cmCH08-18Female 20 cmCH 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

CH 06-10

Tiemann 40

CH 10-14

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	Hi-SlipHydrophilicUrinary Catheter	LoFric® SingleUse UrinaryCatheter, AstraTech Inc.	LoFric® PlusSingle Use Uri-nary Catheter,Astra Tech Inc.	SpeediCathColoplastCorp.
Function ofthedevice	Inserted into thebladder throughthe urethra foremptying thebladder	Inserted into thebladder throughthe urethra foremptying thebladder	Inserted intothe bladderthrough theurethra foremptying thebladder	Inserted intothe bladderthrough theurethra foremptying thebladder
Indicationfor use	Intermittentcatheterization(Because ofchronic urineretention andother voidingdysfunctions.	Intermittentcatheterization	Intermittentcatheterization	Chronic urinere-tention,post-voidresidualvolume (PVR)and voidingdysfunctions.
Featuresof thedevice	Hydrophiliccoated. Slipperysurface. Lowfriction betweencatheter andurethral mucosa.	Hydrophiliccoated. Lowfriction betweencatheterand urethralmucosa.	Hydrophiliccoated. Lowfrictionbetweencatheterand urethralmucosa.	Hydrophiliccoated.Low frictionbetweencatheter andurethralmucosa.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
--	--	----------------------------------------------------------------------------

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Properties	Hi-Slip PlusHydrophilic UrinaryCatheter	LoFric® Primo SingleUse UrinaryCatheter, AstraTech Inc.	SpeediCathColoplastCorp.
510 (k)number		K050874	K023254
Devicecomposition	Polyvinyl chloride(PVC)catheter coatedwith polyvinylpyrrolidone and sterilewater sachet	Polyvinylchloride(PVC) cathetercoated withpolyvinylpyr-rolidone and salt andwater sachet	Polyurethanecatheter coatedwith polyvinylpyr-rolidone, placed ina saline solutioncontainingpolivinyl-pyrrolidone.
Sizes	Male 40 cm,CH08-24Female 20 cm,CH08-18	Male 40 cmCH 10-18Female 20 cmCH 08-18	Male 40 cmCH08-18Female 20 cmCH 06-16
	Boys/Pediatric30 cm, CH06-10Girls/Pediatric20 cm, CH06-10	Pediatric 20 cmCH08-10	Pediatric 20 cmCH 06-10Tiemann 40 cmCH 10-14

		Table 3.3. Hi-Slip Plus-Substantial Equivalence Comparison: General
Properties

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Use	Hi-Slip Plus HydrophilicUrinary Catheter	LoFric® Primo SingleUse UrinaryCatheter, AstraTech Inc.	SpeediCathColoplastCorp.
Function ofthedevice	Inserted into thebladder through theurethra for emptyingthe bladder	Inserted into thebladder through theurethra for emptyingthe bladder	Inserted into thebladder throughthe urethra foremptying thebladder
Indication foruse	Intermittentcatheterization(Because of chronicurine retention andother voidingdysfunctions.	Intermittentcatheterization	Chronic urine re-tention,post-void residualvolume (PVR)and voidingdysfunctions.
Featuresof thedevice	Hydrophilic coated.Slippery surface. Lowfriction betweencatheter andurethral mucosa.Ready to use.	Hydrophilic coated.Low friction betweencatheterand urethral mucosa.Ready to use.	Hydrophiliccoated.Low frictionbetween catheterand urethralmucosa. Ready touse.
Sterility	Sterile	Sterile	Sterile
Packaging	Peel Pack	Closed PVC	Peel Pack

Table 3.4. Hi-Slip Plus-Substantial Equivalence Comparison: Indications for lise

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Properties:	Hi-Slip Kit-Substantial Equivalence Comparison:		General
	Hi-Slip HydrophilicUrinary Catheter Kit	LoFric® PlusHydro-Kit II SingleUse UrinaryCatheter AstratechInc.	EasiCath Set(identical tothe SureCathSet) ColoplastCorp.
510 (k)number		K043241	K973070
Devicecomposition	PVC catheter coatedwith PVP. Then sterilewater sachet povidoneiodine swab and thecatheter are placedinto the urine bag andthe bag is sealed.	Polyvinylchloridecatheter coatedwith polyvinylpyrrolidone and salt.Includes watersachet and urinebag.	Polyvinylchloridecatheter coated withpolyvinylpyrrolidone,packedwith an ampoule withsterile saline solution andsealed in a urinecollection bag.
Sizes	Male 08-18 CHFemale 08-16 CHPediatric Girls 06-10 CHPediatric Boys 06-10CHTiemann 10-18 CH	Male CH 08-18Female CH 08-18Pediatric CH 06-10Tiemann CH 10-18	Male CH 08-18Female CH 08-14Pediatric CH 06-10

. . . .

Table 3.6. Hi-Slip Kit-Substantial Equivalence Comparison: Indications for Use

	Hi-Slip HydrophilicUrinary Catheter Kit	Lofric PlusHydro-Kit II SingleUse Urinary CatheterAstratech Inc.	EasiCath Set(identical tothe SureCathSet) ColoplastCorp
Function ofthe device	Inserted into theurethra till catheterreaches bladder andallows urine to draininto urine collectionbag.	Inserted into theurethra till catheterreaches bladder andallows urine to draininto urine collectionbag.	Inserted into the urethratill catheter reachesbladder and allows urineto drain into urinecollection bag.
Indicationfor use	Intermittentcatheterizationbecause of chronicurine retention andother voidingdysfunctions.	Chronic urineretention andvoiding dysfunctions.	Chronic urine retentionand voidingdysfunctions.
Featuresof thedevice	Hydrophilic coated.Slippery surface. Lowfriction betweencatheter andurethral mucosa.Ready to use.	Hydrophilic coated.Low friction betweencatheter andurethral mucosa.Ready to use.	Hydrophilic coated. Lowfriction betweencatheter and urethralmucosa. Ready to use.

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· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·Sterily	and second address of there a a supportunes ofSterle	a sual challed and different were any are any andwhen and fully for the province ofSterle	A FOR A MONE AND ENGINEER AND ANDSterile
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	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 ofAcute SystemicToxicity Test	Bioserv AnalytikUndMedizinprodukte	Did not cause any acute toxicity,meeting the requirements of ISO10933-11
Closed PatchSensitization Test		Did not cause any sensitization,meeting the requirements of DINISO 10933-10
SalmonellatyphimuriumReverseMutation Assay		Did not cause any genotoxicactivity, meeting the requirementsof DIN ISO 10933-3
CytotoxicityAssay		Caused notoxicological/biological criticalcell damages and growthinhibition. Under these conditionsthe test material is considerednon-cytotoxic and meets therequirements of DIN ISO 10993-5(EN 30993-5)
Skin IrritationTest		Did not cause any irritation underthe selected test conditionsP.I.O.:0,0., meeting therequirements 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 -

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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

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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

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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:

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

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.