The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is indicated for the management of hypopharyngeal fistulae. This is a short term medical device, normally intended for continuous use for not more than 29 days. It needs periodic replacement.

Device Description

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is a bi-flanged silicone device connected with a stretchable (elastomeric) beaded stem. Both flanges are the same diameter for a given size device. The inner flange is flexible enough to allow folding for trans-fistula insertion by a trained physician. The device is fabricated from implant grade silicone. The product will be offered in three sizes: 25mm, 38mm and 50mm. The size is the outside diameter of the sealing flange size options allow the device to accommodate the size of the fistula in the tissue. The three (3) sizes offered are to close fistulas of size between approximately 6 mm diameter and 25 mm diameter, and tissue thickness from approximately 1.5mm to 25mm. The flanges, which are flexible, allow the device to conform to the contours of the tissue at the site yet minimize leakage. The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis Insertion and Removal Catheter is supplied as an accessory to insert or remove the 25 mm and 38 mm Blom-Singer ® Adjustable Bi-Flanged Fistula Prostheses.

AI/ML Overview

The provided text describes the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis, a Class I medical device for managing hypopharyngeal fistulae. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on non-clinical testing and a retrospective clinical review.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it details various non-clinical tests with their outcomes. For the clinical aspect, it reports on the efficacy and safety observed in a retrospective case review.

Acceptance Criteria (Inferred from Non-Clinical Tests and Clinical Review)	Reported Device Performance
Non-Clinical Performance
Non-cytotoxic	Device found to be non-cytotoxic
Non-sensitizing	Device found to be non-sensitizing
Non-irritating	Device found to be non-irritating
Prosthesis closes and seals when placed and adjusted (snug fit)	Met all performance characteristics
Stem does not tear or break when placed and adjusted	Met all performance characteristics
Locking loop functions as designed to prevent loss of proper fit	Met all performance characteristics
Sterility (SAL of 10^-6 at 25 kGy) for Prosthesis	All samples passed sterility
Sterility (SAL of 10^-6 at 25 kGy) for Catheter	All samples passed sterility
1-year and 3-year shelf life (burst, dye migration, label integrity)	Product passed acceptance criteria after 1-year and 3-year accelerated aging
Catheter 1-year and 3-year shelf life (no deterioration/damage)	Met acceptance criteria
Catheter dimensional inspection within tolerance	All samples passed
Catheter eyelet ultimate tensile strength (≥ 2.0 pounds)	All samples met requirement
Catheter eyelet to beaded stem placement tensile strength (≥ 0.5 pounds)	All samples met requirement
Catheter eyelet to beaded stem removal tensile strength (≥ 0.5 pounds)	All samples met requirement
Clinical Performance (Retrospective Review)
Control or elimination of salivary leakage	21 out of 25 (84%) patients reported control/elimination
No serious adverse events	Absence of any serious adverse events reported

2. Sample Size Used for the Test Set and Data Provenance

The primary "test set" for clinical performance was a retrospective review of existing cases.

Sample Size: 25 patients.
Data Provenance: Retrospective review from ten (10) institutions. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the data is likely from the U.S. or North America.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not specify the number of experts or their qualifications used to establish the "ground truth" for the retrospective clinical cases. The review relies on clinical outcomes reported from the institutions that treated the patients with custom-fabricated devices. It states that the custom devices were "technologically similar" to the proposed device.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the retrospective clinical review. It appears to be a summary of reported outcomes from the treating institutions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a retrospective review of clinical cases using a technologically similar device. There is no mention of comparing human readers' performance with and without AI assistance. This device is a physical medical prosthesis, not an AI-powered diagnostic tool.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical prosthesis, not an algorithm or AI system. The design verification testing could be considered a "standalone" evaluation of the physical device's performance characteristics.

7. The Type of Ground Truth Used

For the non-clinical tests (cytotoxicity, sensitization, irritation, performance characteristics, sterility, shelf-life), the "ground truth" was established by accepted industry standards and laboratory testing protocols (e.g., ISO 10993-1:2009 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterilization, physical testing for mechanical properties and shelf life).

For the retrospective clinical review, the "ground truth" was based on reported clinical outcomes from the treating institutions regarding salivary leakage control/elimination and the absence of serious adverse events. This essentially relies on the clinical judgment and patient follow-up records from the physicians involved in those cases.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI. All clinical data presented is from a retrospective "test set" used to demonstrate safety and effectiveness for substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no specific "training set" referenced for an algorithm. The custom-fabricated devices used in the retrospective review could be loosely considered analogous to "training data" in the sense that they provided prior clinical experience for the design of the Blom-Singer® device. However, this is not a formal training set with established ground truth for an AI model.

Summary

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K130736

Submitter's Name, Address, Telephone Number, Contact Person, and Date 5.1 Summary Prepared Company Name: Helix Medical, LLC. A. B. Company Address: 1110 Mark Avenue Carpinteria, CA 93013 C. Company Phone: 1 (805) 576-5308 D. Contact Person: Belinda Jackson Senior Regulatory Affairs Specialist Helix Medical, LLC 1110 Mark Avenue Carpinteria, CA 93013 USA Phone +1 (805) 576-5308 belinda.jackson@helixmedical.com 5.2 Date Summary Prepared December 16, 2013 Name of Device, Including Trade Name and Classification Name 5.3 A. Device Trade Name: Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis B. Common Name: Adjustable Bi-Flanged Fistula Prosthesis C. Classification Name(s): Ear, nose and throat manual surgical instrument D. Classification Regulation: 21 CFR 874.4420 Class I E. Product Code: LRC F. Advisory Panel: Ear, Nose, and Throat Devices Branch

5.4 Predicate Devices

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is substantially equivalent to the Montgomery Radiopaque Salivary Bypass Tube, cleared 510(k) K96268, and the Hood Laboratories Salivary Bypass Tube, cleared under K841350, with respect to indications for use, materials and mechanism of action.

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5.5 Device Description

The product will be offered in three sizes: 25mm, 38mm and 50mm. The size is the outside diameter of the sealing flange size options allow the device to accommodate the size of the fistula in the tissue. The three (3) sizes offered are to close fistulas of size between approximately 6 mm diameter and 25 mm diameter, and tissue thickness from approximately 1.5mm to 25mm. The flanges, which are flexible, allow the device to conform to the contours of the tissue at the site yet minimize leakage.

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis Insertion and Removal Catheter is supplied as an accessory to insert or remove the 25 mm and 38 mm Blom-Singer ® Adjustable Bi-Flanged Fistula Prostheses.

5.6 Indications for Use

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is indicated for the management of hypopharyngeal fistulae. This is a short-term medical device, normally intended for continuous use for not more than 29 days. It needs periodic replacement.

5.7 Comparison of Technological Characteristics

As shown in Table 5.1 below, the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis has the same indications for use, materials and mechanism of action as the predicate devices (Montgomery Radiopaque Salivary Bypass Tube and Hood Salivary Bypass Tube). The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is therefore substantially equivalent to the predicate devices.

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	Device for Clearance	Predicate Device	Predicate Device
Device Name	Blom-Singer® AdjustableBi-Flanged FistulaProsthesis	MontgomeryRadiopaque SalivaryBypass Tube	Hood SalivaryBypass Tube
510(k) Number	K130736	K962688	K841350
Manufacturer	Helix Medical, LLC	Boston MedicalProducts	Hood Laboratories
FDA DeviceClassification	Class I	Class I	Class I
Regulation Number	21 CFR 874.4420	21 CFR 874.4420	21 CFR 874.4420
Product Code	LRC	LRC	ZZZ
Radiopaque	Yes	Yes	No
Intended Use	Management ofhypopharyngeal fistulae	Management ofesophageal andhypopharyngeal fistula	Control salivary.leakage frompharyngocutaneousfistula
Mechanism of action	Directs saliva past fistulakeeping fistula dry; allowsuser to swallow liquids	Directs saliva pastfistula keeping fistuladry; allows user toswallow liquids	Directs saliva pastfistula keeping fistuladry; allows user toswallow liquids
Duration of contactwith tissue	Short term, Less than 29days	Recommended lifetime6 months	Depends on surgeon'sjudgment
Allows eating bymouth and swallowingduring time in situ	Yes	Yes	Yes
Method for insertion	Non-Sedated or sedated	Sedated	Sedated
Supplied sterile?	Yes	No, supplied ready forsterilization	No, supplied readyfor sterilization
Diameters	25mm, 38mm, 50mm	8mm, 10mm, 12mm,14mm, 16mm, 18mm,20mm	8mm, 10mm, 12mm,14mm, 16mm, 18mm,20mm
Material	Implant Grade Silicone	Implant Grade Silicone	Medical gradesilicone

న.8 Brief Summary of Nonclinical Tests and Results

In accordance with ISO 10993-1:2009, cytotoxicity, sensitization, and irritation testing were performed on the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis. The device was found to be non-cytotoxic, non-sensitizing, and non-irritating.

Design verification testing demonstrated that the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis met all performance characteristics established for the device, namely, that the prosthesis closes and seals when placed, adjusted and a snug fit is achieved, the stem does not tear or break when placed and adjusted by a qualified trained medical professional, and the locking loop functions as designed to prevent loss of the proper fit.

The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis and Insertion and Removal Catheter are both sterilized by gamma radiation. Tables 5.2 and 5.3 below provide

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summaries of the sterilization validation test results show that all samples were found to be within the guidelines ANSI/AAMI/ISO 11137-2, Method VDmax25 and sterilization verification was successfully completed.

Table 5.2: Summary of Sterilization Validation Test Results for the Blom-Singer® Bi-Flanged Fistula Prosthesis

Sterilization Characteristic	Value / discussion
Dose Mapping	The verification dose delivered for thesamples had a minimum dose of 8.2 kGy anda maximum dose of 8.6 kGy, which did notvary from the calculated verification dose bymore than ± 10%, the acceptable range.
Bioburden	Overall average of 32.2 colony forming units(cfu)/device; average bioburden less than1000 organisms
Verification Dose	8.4 kGy
Sterility Test Results	All samples passed for sterility and thereforethe sterilization dose of 25 kGy is the 10-6SAL dose for this product.
Bacteriostasis/Fungistasis	Bacteriostatic or Fungistatic characteristicswere not shown to be associated with thesterility cultures of the test article whenchallenged with Bacillus subtilis, ATCC6633, Candida Albicans, ATCC 10231, andAspergillus niger, ATCC 16404.

Table 5.3: Summary of Sterilization Test Results for the Blom-Singer® Bi-Flanged Fistula Prosthesis Insertion and Removal Catheter

Sterilization Characteristic	Value / discussion
Dose Mapping	The verification dose delivered for thesamples had a minimum dose of 5.6 kGy anda maximum dose of 6.8 kGy, which did notvary from the calculated verification dose bymore than $\pm$ 10%, the acceptable range.
Bioburden	Overall average of 4.13 colony forming units(cfu)/device; average bioburden less than1000 organisms
Verification Dose	6.2 kGy
Sterility Test Results	All samples passed for sterility and thereforethe sterilization dose of 25 kGy is the 10-6SAL dose for this product.
Bacteriostasis/Fungistasis	Test results are contingent upon the samplesnot being Bacteriostatic or Fungistatic astested. Test article was challenged withBacillus subtilis, ATCC 6633, CandidaAlbicans, ATCC 10231, and A. brasiliensis,ATCC 16404.

Accelerated aging testing to support a three (3)-year shelf life for the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis has been completed. Samples were evaluated for the effects of aging after 1-year, 2-year and 3-year. The product accelerated aging

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study tests were successfully completed and passed the acceptance criteria for burst test, dve migration test, and label integrity. Post-accelerated aging study design verification testing was performed and the test results of the samples packaged, sterilized, and accelerated-aged for 1-yr and 3-yr satisfied the acceptance criteria thereby verifying that sterilization and 3-year aging has no detrimental impact to the safety and efficacy of the Blom-Singer® Bi-Flanged Fistula Prosthesis.

Accelerated aging testing to support a three (3)-year shelf life for the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis Insertion and Removal Catheter has also been completed. One year and three year accelerated aged samples met the Acceptance Criteria: The samples for the time period 1-year and 3-year were inspected and found no signs of deterioration or damage. All burst and dye tested pouches met the acceptance criteria. The following additional tests were also performed on the 1-year and 3-year samples:

. Dimensional Inspection - All samples were within the drawing tolerance allowances and pass.
Ultimate Tensile Strength Force Test for eyelet All samples met the pull test . requirement of ≥ 2.0 pounds.
Tensile Strength Force Test for eyelet to beaded stem (Placement) All samples . met the pull test requirement of ≥ 0.5 pounds.
Tensile Strength Force Test for eyelet to beaded stem (Removal) All samples . met the pull test requirement of ≥ 0.5 pounds.

All the 3 year accelerated aged product samples had been previously used to successfully place and remove fistula devices.

Real Time Aging studies are underway for the Fistula Prosthesis and the Insertion and Removal Catheter.

5.9 Brief Summary of Retrospective Clinical Cases

A retrospective review was conducted of twenty-five (25) patients treated for pharvneocutaneous and other similar fistulas at ten (10) institutions with custom-fabricated adjustable bi-flanged fistula prostheses. The custom-fabricated fistula prostheses were manufactured using commercially-available grade silicone and are technologically similar to the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis. The devices are comprised of a single or double silicone stem and two flanges which were sized to meet the specific needs of the patient.

The patients ranged in age from 36-87 years of age and consisted of 15 males and 10 females. The duration the prosthesis remained in place ranged from 2 days to 24 months. Of the 25 patients treated, 21 (84%) were reported to control or eliminate salivary leakage. The size of the fistula decreased in 11 out of 25 (44%) of the patients.

The review of the clinical experience demonstrated that the device provided a safe and effective alternative for managing salivary fistulas. The majority of patients treated using

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this modality were able to control or eliminate salivary leakage in the absence of any serious adverse events.

Substantial Equivalence 5.10

On the basis of the same indications for use, materials and mechanism of action as shown in Table 5.1, and the results of the nonclinical tests described in section 5.8, the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 17, 2013

Helix Medical, LLC Ms. Belinda Jackson Senior Regulatory Affairs Specialist · 1110 Mark Avenue Carpinteria, CA 93013-2918

Re: K130736

Trade/Device Name: Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: November 13, 2013 Received: November 15, 2013

Dear Ms. Jackson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Belinda Jackson

・・・ 1. 13. 1.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130736

Device Name: Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sunny Park 2013.12.16 10:12:09 -05'00'

Page 1 of

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.