Who is the manufacturer of BioHealx Anal Fistula Device?

Signum Surgical Limited filed the De Novo classification request for BioHealx Anal Fistula Device (DEN240007).

What is the FDA product code for BioHealx Anal Fistula Device?

QML. It is classified under 21 CFR 878.4835 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for BioHealx Anal Fistula Device?

De Novo classification (submission type: Direct).

Who can help prepare an FDA De Novo submission like BioHealx Anal Fistula Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA De Novo submissions. See https://innolitics.com/services/regulatory/ or contact https://innolitics.com/contact.

BioHealx Anal Fistula Device

DEN240007 · Signum Surgical Limited · QML · Jul 1, 2024 · General, Plastic Surgery

Device Facts

Record ID	DEN240007
Device Name	BioHealx Anal Fistula Device
Applicant	Signum Surgical Limited
Product Code	QML · General, Plastic Surgery
Decision Date	Jul 1, 2024
Decision	DENG
Submission Type	Direct
Regulation	21 CFR 878.4835
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Signum Surgical BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.

Device Story

BioHealx Anal Fistula Device is a surgical implant system for anal fistula repair. It consists of a sterile, single-use, helical, barbed bioabsorbable implant (PLGA) and a disposable delivery device. The physician uses the delivery system to rotate the helical implant into soft tissue surrounding the fistula's internal opening. The implant's tapered geometry gathers and compresses sphincter muscle tissue, achieving closure via direct tissue apposition. Barbs provide anchorage to prevent migration. The implant remains in place for 4-6 weeks to support healing and is absorbed within 6-12 months. The procedure is performed by colorectal or general surgeons in a clinical setting. The device simplifies treatment by standardizing delivery depth and positioning, potentially reducing recurrence and avoiding sphincter damage associated with traditional surgical techniques like fistulotomy.

Clinical Evidence

Prospective, non-randomized, multi-center study (N=32) in adults with recurrent transsphincteric fistulas. Primary endpoint: fistula closure (absence of drainage) at 12 months. Results: 59.4% (19/32) fully healed; 31.2% (10/32) downgraded to sinus/superficial; 9.4% (3/32) recurrence. No incontinence or sphincter damage reported. 71% reduction in mean pain score. Safety profile acceptable; one serious adverse event (unrelated wound bleeding). Bench testing and porcine animal model (N=6) supported safety and device integrity.

Technological Characteristics

Surgical implant for anal fistula repair. May be manually applied or delivered via delivery system. Special controls require evaluation of material composition (including dyes/coatings), mechanical strength of implant, mechanical integrity of delivery system, and for absorbable versions, residual strength and absorption rates. Must be biocompatible and sterile. Shelf life must be supported by data on sterility, package integrity, and functionality.

Indications for Use

Indicated for closure of internal opening of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition in adults (18+). Contraindicated in patients with Crohn's disease, pregnancy, known allergy to PLGA, or fistulas with direct anatomic relationship to major vascular structures. Not for use in fistulas <2cm.

Regulatory Classification

Identification

An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device.

Related Devices

K162388 — CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) · Curaseal, Inc. · Feb 3, 2017
K150668 — Biodesign Enterocutaneous Fistula Plug · Cook Biotech Incorprated · Dec 9, 2015
K083266 — GORE BIO-A FISTULA PLUG · W. L. Gore & Associates, Inc. · Mar 27, 2009
K170016 — Biodesign Fistula Plug · Cook Biotech Incorporated · Jun 21, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ ### DE NOVO CLASSIFICATION REQUEST FOR BIOHEALX ANAL FISTULA DEVICE #### REGULATORY INFORMATION FDA identifies this generic type of device as: Anal fistula closure device. An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device. NEW REGULATION NUMBER: 21 CFR 878.4835 CLASSIFICATION: Class II PRODUCT CODE: QML #### BACKGROUND DEVICE NAME: BioHealx Anal Fistula Device SUBMISSION NUMBER: DEN240007 DATE DE NOVO RECEIVED: February 2, 2024 #### SPONSOR INFORMATION: Signum Surgical Limited Galway Harbour Enterprise Park, New Docks, The Docks Galway H91 NNY6 Ireland #### INDICATIONS FOR USE The BioHealx Anal Fistula Device is indicated as follows: The Signum Surgical BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition. ### LIMITATIONS The sale, distribution, and use of the BioHealx Anal Fistula Device are restricted to prescription use in accordance with 21 CFR 801.109. Contraindications {1}------------------------------------------------ - The BioHealx Anal Fistula Device should only be used for the repair of anal fistulas. - . This device should not be used in tissues that have a direct anatomic relationship to major vascular structures. ## Key Limitations - The BioHealx Anal Fistula Device should be used only by physicians having adequate ● training and familiarity with the implant technique. - The BioHealx implant is suitable only for use in fistulas of any length greater than 2cm. ● - The BioHealx device has not been evaluated in patients with Crohn's disease. ● - The device should not be used in pregnant women. ● - The device should not be used in patients with a known allergy to poly (lactic-co-glycolic acid), (PLGA). - Do not attempt anterior delivery in females, to prevent implant penetration through the vaginal wall. - Do not deliver at external opening of fistula tract. - Remove implant if not completely delivered. ● # PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. ## DEVICE DESCRIPTION The BioHealx Anal Fistula Device comprises the BioHealx Implant and the Delivery System. The BioHealx implant is designed as a sterile, single use helical, barbed bioabsorbable implant intended to promote healing by primary intention. The BioHealx delivery device is a sterile single-use, disposable delivery device that rotates the implant into the soft tissue surrounding the internal opening of the fistula tract. The BioHealx implant apposes the internal opening of the fistula channel and is held in position by its design geometry. The implant is fully enclosed in the anal sphincter muscle tissue and is not exposed to the ano-rectal canal. The implant retains adequate strength to compress the tissue of the internal opening of a fistula for 4 - 6 weeks and is absorbed within 6 - 12 months. ## BioHealx Implant The BioHealx implant is designed as a coil, with a tapered inner surface. The coil design facilitates insertion around the fistula tract lumen at the internal opening. The sphincter muscle tissue surrounding the fistula internal opening is gathered and compressed by the implant's internal taper geometry during implant delivery, effecting closure of the internal opening by direct tissue apposition. {2}------------------------------------------------ Image /page/2/Figure/0 description: The image shows a 3D rendering of a medical device. The device has a cylindrical shape with barbs protruding from the surface. The text labels indicate the presence of barbs and a tapered internal lumen. Figure 1 Signum Surgical BioHealx™ Anal Fistula implant. The anti-rewind features ("barbs") (Figure 1) at the outer perimeter of the implant serve as retention features to prevent the device migration/extrusion once implanted. The implant is centered around the fistula tract at the internal opening in the sphincter muscle complex, causing the fistula to close within the tapered internal lumen of the implant. ## Degradation The constituent implant material is poly (lactic-co-glycolic acid), (PLGA). Poly (lactic-coglycolic acid), (PLGA) is a material that degrades by hydrolysis (i.e., degradation takes place in the presence of water). The progression of the absorption process proceeds from loss of mechanical strength followed by loss of physical structural integrity marked by fragmentation followed by breakdown to microscopic residue and ultimate elimination from the body. Non-clinical bench testing (invitro) found that the loss of physical structural integrity has occurred by week 26 (6 months). Biocompatibility testing (26-week implantation study) found that only test article fragments (i.e., mostly degraded) could be identified. ## BioHealx Delivery System The BioHealx implant is delivered to the operative site by means of a single-use disposable delivery device (Figure 2) that is preloaded with the implant (Figure 3). The BioHealx delivery system controls the positioning and depth of delivery of the implant, standardizing the procedure and reducing operator variability. {3}------------------------------------------------ Image /page/3/Figure/0 description: The image shows a medical device with a white handle and a curved metal tip. The device has a gray knob at the end, followed by a green lock. The text labels in the image identify the different parts of the device, including the device handle, knob, and lock. Figure 2 Signum Surgical BioHealx Anal Fistula delivery system. Image /page/3/Picture/2 description: The image shows a close-up of two metal tools with a spiral cutting edge. The tools are silver in color and have a cylindrical shape. The cutting edge is made up of a series of small, sharp teeth that are arranged in a spiral pattern. The tools appear to be used for cutting or drilling materials, and the spiral cutting edge helps to remove material as the tool rotates. on Driver Coil Image /page/3/Picture/3 description: The image shows a CAD rendering of a curved pipe with a transparent section revealing an internal helix structure. An additional helix component is detached and positioned to the right of the pipe's opening. The pipe is light gray, while the detached helix is a darker shade of blue. (a) Photographic Image of Implant loaded (b) 3-Dimensional Model of Implant detached from Driver Coil ## Figure 3 BioHealx implant preloaded to BioHealx delivery system. A stainless-steel wire suture attachment loop extends 3mm to 5mm beyond the distal end of the device (see Figure 4). The suture attachment loop provides an easy access point allowing the user to attach a commercially available USP size 2-0, braided, coated synthetic absorbable suture for delivery device guidance prior to implant delivery. The suture attachment loop is attached internally to the lock component at the proximal end of the delivery device and is retracted with the lock retraction prior to implant delivery. {4}------------------------------------------------ Image /page/4/Figure/0 description: The image shows a medical device with several labeled parts. The parts labeled are the device handle, lock, knob, shaft, and suture attachment loop. There is also a close up of the suture attachment loop with a suture attached. Figure 4 BioHealx Delivery System with Suture Attachment Wire Loop Turning the delivery system knob clockwise (three full turns) rotates the implant driver coil clockwise to deliver the helical implant circumferentially to surround the internal opening of the fistula to the predefined depth controlled by the driver coil. The internal drive mechanism has a one-way ratchet to ensure the user deploys the device fully; a series of audible clicks will be heard during the knob rotation. After the implant is fully delivered the knob can no longer be turned ('bottoms out'), signaling to the user to begin retraction via counterclockwise rotation of the knob. The barbs (Figure 1) that radially extend from the implant provide anchorage in the tissue releasing the implant from the driver coil and leaving the implant to remain surrounding the internal opening of the fistula tract. Once the driver coil is retracted, the user removes the delivery device from the patient. ### SUMMARY OF NONCLINICAL/BENCH STUDIES Non-clinical/Bench studies conducted on the BioHealx Anal Fistula Device demonstrate safety and effectiveness and are summarized below. | Test | Purpose | Method | Acceptance Criteria | Results | |------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Implant Verification Testing | Demonstrate that the BioHealx Implant maintains sufficient strength to support tissue healing for a minimum of 3 weeks post implant delivery (a strength equal to or greater than (b) (4) | The break strength was evaluated at T=0, 3, 4, 6 weeks following simulated in-vitro degradation in buffer solution at (b) (4) | Tensile (implant break) strength must be (b) (4) (T=0) and (b) (4) (T=3 weeks, 4 weeks, 6 weeks). | All testing passed the acceptance criteria. | | Delivery Mechanism Verification | Demonstrate that the BioHealx delivery mechanism is capable of successful implant delivery. Determine the torque requirement to remove | Each test sample (Finished Device) was removed from the packaging and verified to meet specifications. The BioHealx implant was delivered to between (b) (4) | a) The BioHealx Anal Fistula Device must be capable of consistent successful delivery of the BioHealx implant, to a controlled depth, being delivered to simulated tissue. | All testing passed the acceptance criteria. | | Test | Purpose | Method | Acceptance Criteria | Results | | | an implant from the drive coil assembly (implant lock testing). | into the simulated tissue surface. | b) The drain capture mechanism must be capable of withstanding a (b) (4) load without failure and allow attachment of USP size 2-0 bioabsorbable suture via a secure knot. c) The implant must maintain integrity and form (geometry) post implant delivery. | | | Implant Migration | Demonstrate resistance to migration / extrusion of the BioHealx implant. | The BioHealx implant resistance to migration/extrusion was evaluated under the conditions of simulated rectal pressure cycling on BioHealx implant position. All bench testing was performed in an anatomically relevant model. | a) The applied force required to cause implant migration and extrusion force in the gel model must be (b) (4) axial force (b) (4) b) The BioHealx implant final position (post pressure cycling) must remain within the required delivery depth specification of (b) (4) (b) (4) | All testing passed the acceptance criteria. | | Drain Attachment | Demonstrate that the drain capture mechanism is: - Capable of withstanding anticipated loading - Allows attachment of 2-0 bioabsorbable suture using a secure knot. - When attached to suture (drain capture/suture assembly) can withstand anticipated loading while (i) retracting the lock and (ii) post retraction of lock. | Each test sample (Finished Device) was removed from the packaging and tested on the bench to ensure that the drain capture mechanism could withstand the anticipated loading. | a) Drain capture mechanism must withstand an applied load (b) (4) without failure. b) Drain capture mechanism shall allow attachment of 2-0 bioabsorbable suture using a secure knot. c) Drain capture/ suture assembly must withstand an applied (b) (4) load while (i) retracting the lock and (ii) post retraction of lock. | All testing passed the acceptance criteria. | | Test | Purpose | Method | Acceptance Criteria | Results | | Drain Release Force | Assessment of the force required to release the suture /drain from a delivered BioHealx implant. | BioHealx implants were delivered to a simulated fistula tract in a representative model. For each fistula tract/implant delivered, a simulated drain using suture material was created. A tensile load was applied to each drain to determine the force required to cause detachment. | This testing was used to collect representative data to determine the force required to release the suture/drain from a delivered BioHealx implant. | The average force (95%/95% confidence reliability) required to release the stop knot (3 throws of a figure 8) and to cause the drain to detach was (4) Kg equivalent.) | | In Vivo Performance Testing (GLP) | Evaluate the safety and performance of the BioHealx Anal Fistula Device for its intended use to appose tissues in the repair of anal fistulas using a porcine anal fistula model. | Cohort of six (6) pigs (species strain Sus scrofa scrofa/ domestic. Yorkshire cross – white) were treated in the study. - Four perianal fistulas, with a seton placed, were created at the 3,5,7 and 9 o'clock positions in each animal. - After 4-weeks recovery, a second surgical procedure was performed per the BioHealx implant procedure. This involved the creation of a small mucosal incision at the internal opening site, and partial fistulectomy as necessary followed by placement of the BioHealx device in each of the fistula tracts. | Animals were observed for any adverse clinical signs of disease or ill health. Fistula healing, as assessed by histopathology analysis. Determine that the BioHealx device does not adversely affect the incidence and rate of perianal healing nor have any detrimental effect as determined by histopathology). | All testing passed the acceptance criteria. Testing concluded that there was no evidence of adverse tissue reaction associated with the BioHealx device in any of the evaluated samples. | | Human Factors/ Summative Evaluation Testing | Demonstrate the components of the BioHealx system can be used by the intended users without serious use errors or problems, | Users: 7 x EU, 10 x US representative colorectal surgeons. 100% (17/17) participants performed | a) User must unpackage the device without causing damage to the device. b) User must remove the device from the tray | All implanters successfully completed implant training and effectiveness evaluation. | | Test | Purpose | Method | Acceptance Criteria | Results | | | for the intended uses and under the expected use conditions. The specific objectives are: - Confirm that the BioHealx device can be safely delivered. - Confirm that the BioHealx device can be effectively delivered. - Confirm no unanticipated serious use errors attributable to the system user interfaces. - Evaluate the simulated model as an effective training tool for BioHealx system users. | several BioHealx implantations in an anatomically relevant simulated use bench top model. Clinical investigators (N=6) also completed an in vivo simulated use (porcine) animal model. Note: The human factors simulated use in vivo testing was for training effectiveness evaluation only and was a separate activity to the GLP in vivo performance testing (described above). | without damage to the device (e.g., drop device) c) User feedback on the tissue stabilization features must not identify risks/complaints. d) User must not cut gloves/cause self-injury during device use. e) User must successfully attach suture to the device attachment loop. f) User must successfully place speculum and must not complain about device interface experience with speculum. | The objectives to confirm that the BioHealx device can be safely and effectively delivered were met. There were no close calls or use errors observed during the evaluation. The simulated use model was demonstrated to be an effective training tool. | | Biocompatibility Testing - Implant. Rabbit Blood Hemolysis Test. | To determine the potential hemolytic activity, via the induction of increased levels of free plasma hemoglobin in rabbit blood, in response to the BioHealx implant test article and its extract. | ASTM F756, ISO 10993-12, ASTM F619 | Acceptance criteria per ISO 10993-4 (2017), ISO 10993- 12 (2012), ASTM F756-17, ASTM F619-14. | All testing met the acceptance criteria. The BioHealx implant was determined to be non-hemolytic. | | Biocompatibility Testing - Implant. 90-Day Systemic Toxicity in Rats via Intramuscular Implantation. | To determine the toxicity potential of a test material administered by muscle implantation in rats for 90-days. | ISO 10993-6 (2016), ISO 10993-11 (2017), OECD 408, ISO 10993-12 (2012). | Acceptance criteria per ISO 10993-6 (2016), ISO 10993- 11 (2017), OECD 408, ISO 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx implant did not demonstrate any local or systemic signs of toxicity when implanted in rats for 90- days. | | Biocompatibility Testing - Implant. 26-week Systemic Toxicity in Rats via | To determine the toxicity potential of a test material administered by muscle implantation in rats for 26-weeks. | ISO 10993-6 (2016), ISO 10993-11 (2017), OECD 408, ISO 10993-12 (2012). | Acceptance criteria per ISO 10993-6 (2016), ISO 10993- 11 (2017), OECD 408, ISO 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx implant did not demonstrate any local or systemic signs of toxicity when implanted in rats for 26-weeks. | | Test | Purpose | Method | Acceptance Criteria | Results | | Intramuscular Implantation. | | | | in rats for 26 weeks. | | Biocompatibility Testing - Implant. Intracutaneous Injection Test - ISO | To determine the potential irritation effects of the BioHealx implant test article extract after intracutaneous injection in New Zealand White rabbits | ISO 10993-10 (2010), ISO 10993-12 (2012). | Acceptance criteria, per ISO 10993-10 (2010), ISO 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx test article met the requirements of the ISO 10993-10. | | Biocompatibility Testing - Implant. Kligman Maximization Test – ISO (Sensitization) | To determine the potential allergenic or sensitizing capacity of the BioHealx test article. | ISO 10993-10 (2010), ISO 10993-12 (2012). | Acceptance criteria per ISO 10993-10 (2010), USP 141, ISO 10993-12 (2012). | The BioHealx test article met the requirements of the ISO 10993-10. All testing met the acceptance criteria. | | Biocompatibility Testing - Implant. L929 Neutral Red Uptake Test (4 Conc'ns) - ISO | To determine the potential biological reactivity of a mammalian cell culture (L929) in response to the BioHealx implant test article extract. | ISO 10993-11 (2017), ISO 10993-12 (2012). | Acceptance criteria per ISO 10993-5 (2009), ISO 10993- 12 (2012). | All testing met the acceptance criteria. The BioHealx test article met the requirements of ISO 10993-5. | | Biocompatibility Testing – Implant. Systemic Injection Test - ISO | To determine the potential toxic effects of the BioHealx implant test article extract as a result of a single-dose systemic injection in mice. | ISO 10993-11 (2017), ISO 10993-12 (2012). | Acceptance criteria per ISO 10993-11 (2017), ISO 10993-12 (2012) | All testing met the acceptance criteria. The BioHealx test article met the requirements of ISO 10993- 11. | | Biocompatibility Testing - Implant. Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay - ISO | To determine the potential mutagenicity of the BioHealx implant test article extract on various strains of Salmonella typhimurium (S. typhimurium) and Escherichia coli (E. coli) bacteria, via a change in their dependence for histidine or tryptophan. | ISO 10993-3, 2014 ISO/TR 10993-33, 2015 OECD 471 ISO 10993-12, 2012, | Acceptance criteria per ISO 10993-3(2014), ISO/TR 10993-33 (2015), Part 33, OECD 471, ISO 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx implant test article was found to be non- mutagenic. | | Biocompatibility Testing - Implant. Mouse Lymphoma | To determine the potential mutagenicity effect on mouse lymphoma cells (heterozygous thymidine kinases | ISO 10993-3 (2014), ISO 10993-33 (2015), OECD 490, ISO 10993-12 (2012). | Acceptance criteria per ISO 10993-3 (2014), ISO 10993- 33 (2015), OECD 490, ISO 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx implant test | | Test | Purpose | Method | Acceptance Criteria | Results | | Mutagenesis Assay - ISO | mutant TK(+L5178Y) in response to the BioHealx implant test article extract. | | | article was found to be non- mutagenic. | | Biocompatibility Testing - Implant. Intramuscular Implantation Test for Absorbable/Deg radable Materials - ISO 2-week implantation | To evaluate the BioHealx implant test article for local tissue responses and the potential to induce local toxic effects after implantation (for 2- weeks) in the muscle tissue of albino rabbits. Absorption of the test article was assessed. | ISO 10993-6 (2016), 10993-12 (2012). | Acceptance criteria per ISO 10993-6 (2016), 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx implant test article was considered non- reactive and met the requirements of ISO 10993-6. | | Biocompatibility Testing - Implant. Intramuscular Implantation Test for Absorbable/ Degradable Materials - ISO 8-week implantation | To evaluate the BioHealx implant test article for local tissue responses and the potential to induce local toxic effects after implantation (for 8- weeks) in the muscle tissue of albino rabbits. Absorption of the test article was assessed. | ISO 10993-6 (2016), 10993-12 (2012). | Acceptance criteria per ISO 10993-6 (2016), 10993-12 (2012). | All testing met the acceptance criteria. The BioHealx implant test article was considered non- reactive and met the requirements of ISO 10993-6. | | Biocompatibility Testing - Implant. Rabbit Pyrogen Test (Material Mediated) - ISO | To determine the potential presence of chemical pyrogens in extracts of solid materials in order to limit to an acceptable level the risk of febrile reaction following administration of the BioHealx implant (product) to a patient. | ISO 10993-11 (2017), 10993-12 (2012). | Acceptance criteria per ISO 10993-11 (2017), 10993-12 (2012). | All testing met the acceptance criteria. The results supported that the BioHealx implant is non- pyrogenic and meets the requirements of the Pyrogen Test, ISO 10993-11. | | BioHealx Implant Endotoxins Test Validation | To validate the gel clot lysate method for endotoxin testing | 10993-12 (2012). | Study was conducted based on USP 41, NF 36 (2018), <85> Bacterial Endotoxins Test, 10993-12 (2012). | The test articles, Signum Surgical BioHealx, meet the requirements of the Amoebocyte Lysate Endotoxin Validation Test, Gel Clot Method | | Test | Purpose | Method | Acceptance Criteria | Results | | | | | | according to the USP guidelines. The test articles do not inhibit or enhance the assay. | | | | | | All testing met the acceptance criteria. | | BioHealx Delivery System ISO Guinea Pig Maximization Sensitization Test | To evaluate the potential of the BioHealx Delivery Device test article extract to cause delayed dermal contact sensitization in the guinea pig maximization test. The Magnusson and Kligman method has been effective in identifying a variety of allergens. | 10993-10 (2021), 10993-12 (2021) | Acceptance criteria per ISO 10993-10 (2021), 10993-12 (2021). | All testing met the acceptance criteria. The BioHealx Delivery System test article was not considered a sensitizer in the guinea pig maximization test. | | BioHealx Delivery System Cytotoxicity Study Using the ISO Elution Method | To determine the potential of a test article extract to cause cytotoxicity. | ISO 10993-5 (2009), 10993-12 (2021).…