(58 days)
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
The SpeedStitch System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The needle cassette and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
The provided text describes a 510(k) premarket notification for the "SpeedStitch Suture Passer System." This is a medical device submission, and the information primarily focuses on demonstrating substantial equivalence to predicate devices through design verification and non-clinical testing. It does not involve a study proving the device meets acceptance criteria in the way this request implies (e.g., clinical trials with specific performance metrics like sensitivity, specificity, or reader agreement).
However, I can extract the relevant information regarding design verification and non-clinical testing that serves as the "study" proving the device meets its design specifications, which are a form of acceptance criteria in this context.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical performance targets and reported values. Instead, it broadly states that "Design Verification testing was performed in order to verify the design outputs meet the design inputs" and "The test results demonstrate that the proposed SpeedStitch meets its design, performance, and safety specifications."
The "acceptance criteria" here are implied to be the successful fulfillment of design inputs and performance specifications during bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Verify design outputs meet design inputs | Design Verification testing was performed. Test results demonstrate the proposed SpeedStitch meets its design, performance, and safety specifications. |
| Grasping of tissue model with suture passer | Successfully performed in in vitro testing. |
| Insertion of needles through tissue model | Successfully performed in in vitro testing. |
| Capturing suture from suture cartridges | Successfully performed in in vitro testing. |
| Suture successfully pulled through tissue model using suture passer | Successfully performed in in vitro testing. |
| Affirm safety and effectiveness during simulated use | Simulated use testing was performed on the device and accessory devices (suture cartridges). Test results demonstrate the proposed SpeedStitch performs as intended and mechanical properties are substantially equivalent to the predicate device. |
| Performance as intended | All testing demonstrates that the proposed SpeedStitch performs as intended and has acceptable performance when used in accordance with the labeling. |
| Mechanical properties substantially equivalent to predicate device | Test results demonstrate mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "bench testing," "in vitro testing," and "simulated use testing," but does not quantify the number of devices, tests, or tissue models used.
- Data Provenance: The testing was "in vitro" (bench testing) and "simulated use testing." This implies laboratory testing rather than real-world clinical data. There is no mention of country of origin as it's a non-clinical submission. The testing would be considered prospective for the specific tests performed as they were conducted to support this submission.
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. This was a non-clinical device submission relying on engineering and performance testing. There was no "ground truth" derived from expert interpretation of data like in an AI/diagnostic device context. The "ground truth" for these tests would be the established design specifications and performance parameters measured by engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was mentioned or would typically be used for this type of non-clinical device testing. Performance was assessed against predefined engineering specifications.
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
No. An MRMC comparative effectiveness study was not done. This device is a surgical instrument (suture passer), not a diagnostic or AI-assisted system for human interpretation. The submission explicitly states: "No clinical or animal data are included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "test set" (bench and simulated use testing), the "ground truth" was the design specifications and performance requirements established for the device. These tests aimed to verify that the device's actual performance met these predetermined engineering and functional requirements.
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not a learning algorithm or AI system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As no training set was used, no ground truth needed to be established for it.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
ArthroCare Corporation Ms. Laura Kasperowicz Principle RA Specialist 15285 Alton Parkway Suite 200 Irvine, California 92618
Re: K163142
Trade/Device Name: Speedstitch Suture Passer; Speedstitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; Speedstitch Needle Loader And Unloader Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, NBH, HXK Dated: November 7, 2016 Received: November 9, 2016
Dear Ms. Kasperowicz:
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.
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
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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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
SpeedStitch Suture Passer System
Indications for Use (Describe)
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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November 7, 2016
510(k) Summary
ArthroCare® Corporation
SpeedStitch® System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation, a Smith & Nephew Company |
|---|---|
| Address: | 15285 Alton Parkway, Suite 200Irvine, CA. 92618 |
| Contact Person: | Laura KasperowiczPrinciple Regulatory Affairs SpecialistPhone: 949-585-2406Fax: 949-585-2401 |
| Date Prepared: | November 7, 2016 |
Device System Names/Components
The SpeedStitch System is a Class II device consisting of the following components:
| Proprietary: | SpeedStitch Suture Passer |
|---|---|
| Common: Suture Passer | |
| Classification: Class I | |
| Product Code: NBH | |
| CFR Section: 21 CFR 888.1100 | |
| Proprietary: | SpeedStitch Needle Cassette |
| Common: Holder, Needle, Orthopedic | |
| Classification: Class I | |
| Product Code: HXK | |
| CFR Section: 21 CFR 888.4540 | |
| Proprietary: | Suture Cartridge containing MagnumWire® Suture |
| Common: Suture, Nonabsorbable, Synthetic, Polyethylene | |
| Classification: Class II | |
| Product Code: GAT | |
| CFR Section: 21 CFR 878.5000 |
Predicate Device
The SpeedStitch System is substantially equivalent to the following:
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Description
The SpeedStitch System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The needle cassette and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
Intended Use/Indications For Use
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Non-Clinical Data
Bench testing was performed on both the proposed and predicate devices. This in vitro testing involved grasping of a tissue model with the suture passer, insertion of needles through the tissue model and capturing suture from suture cartridges, which was successfully pulled through the tissue model using the suture passer. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices (suture cartridges) which will be promoted for use with the SpeedStitch system in order to affirm safety and effectiveness.
The test results demonstrate that the proposed SpeedStitch meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the proposed SpeedStitch performs as intended and has acceptable performance when used in accordance with the labeling.
As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the proposed SpeedStitch System is substantially equivalent. The minor differences between the proposed SpeedStitch System and predicate device do not raise any new questions of safety or effectiveness.
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ArthroCare® Corporation Premarket Notification
SPEEDSTITCH® SYSTEM
November 7, 2016
| Comparison of Device Characteristics | |||
|---|---|---|---|
| Parameter | M-Connector UltraPredicate Device | SpeedStitchPredicate Device | SpeedStitchProposed Device |
| 510(k) | K121306 | K042031 | TBD |
| Panel | General & Plastic Surgery,Orthopedic | Same | Same |
| Product Code(s) | GAT & NBH | GAT | GAT/NBH/HXK |
| Classification Section | 878.5000888.1100 | 878.5000 | 878.5000888.1100888.4540 |
| Classification Name | > Suture, Nonabsorbable,Synthetic, Polyethylene> Arthroscope & Accessories(Suture Passer) | > Suture, Nonabsorbable,Synthetic, Polyethylene | > Suture, Nonabsorbable,Synthetic, Polyethylene> Arthroscope & Accessories(Suture Passer)> Holder, Needle, Orthopedic |
| Device Classification | Class II (Sutures) &Class I (Handle, Connector) | Class II | Class II (Sutures),Class I (Handle),Class I (Needle Holder) |
| Intended Use | For use in the placement ofsuture(s) through soft tissue inarthroscopic and limited accessprocedures. | For use in the placement ofsuture(s) through soft tissue inendoscopic and limited accessprocedures. | For use in the placement ofsuture(s) through soft tissue inarthroscopic and limited accessprocedures. |
| Design Technology | Suture Passer with 2 needles | Suture Passer with 1 needle | Suture Passer with 1 needle |
| Suture DeliveryMethod | Suture preloaded in a cartridgefor arthroscopic or limitedaccess delivery | Same | Same |
| Suture Specifications | USP #2 NonabsorbableSynthetic Suture,Polyethylene | Same | Same |
| Suture Placement | Interrupted Mattress Stitch | Simple Stitch | Simple Stitch |
| Main Components | ■ Handle■ Connector■ Suture Cartridge withsuture | ■ Handle with Connector■ Suture Cartridge withsuture■ Needle Loader & NeedleExtractor | ■ Handle with Connector■ Suture Cartridge withsuture■ Needle Loader & NeedleExtractor |
| Main Materials | 300/301/304/316 Stainless Steel17-4/17-7/455 Stainless SteelPolycarbonateGlass Filled NylonUV Adhesive | Same | Same |
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.